Reusable aseptic fluid couplings

ABSTRACT

Some fluid coupling devices described herein are configured for use in fluid systems for purposes of providing a repeatable, aseptic fluid coupling system. Such repeatable, aseptic fluid coupling systems are configured to facilitate multiple connection and disconnection cycles while repeatably establishing a sterile fluid pathway through the coupling system. The repeatable, aseptic fluid coupling systems can repeatably establish a sterile fluid pathway through the coupling system even though the coupling system may be used in a non-sterile environment.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.15/288,162, filed Oct. 7, 2016, which claims the benefit of U.S.Provisional Application Ser. No. 62/238,870, filed Oct. 8, 2015. Thedisclosures of the prior applications are considered part of (and areincorporated by reference in) the disclosure of this application.

BACKGROUND 1. Technical Field

This document relates to fluid coupling devices for fluid systems andmethods. For example, some embodiments described in this document relateto reusable aseptic fluid coupling devices that isolate fluids flowingthrough the coupling devices from the surrounding environment.

2. Background Information

In the bioprocessing field, manufacturers have been transitioning fromfluid handling systems that use fixed, reusable equipment (e.g., madeprimarily of stainless steel) to single-use fluid handling equipment(e.g., made primarily of plastics). In some cases, the single-use fluidhandling equipment is supplied pre-sterilized and is disposed of afteruse. With this type of equipment, there is a need to make connectionsand disconnections that maintain sterility during the connection anddisconnection actions. The need is particularly acute in the context oflower classification (e.g., less sterile) environments.

There are fluid coupling technologies used in the bioprocessing fieldthat can provide a sterile connection, and there are fluid couplingtechnologies that can provide a sterile disconnection. In many cases,however, these fluid coupling systems do not repeatably provide both asterile connection and a sterile disconnection. As a result, in somecases complex single-use tubing assemblies are employed to make multiplesterile connections and disconnections. Such complex assemblies may tendto increase process equipment costs and to reduce processingefficiencies.

SUMMARY

This document describes a number of fluid coupling devices and systemsfor use in fluid handling systems and methods. In some embodiments, thefluid coupling devices and systems can be implemented as repeatable,aseptic fluid coupling systems. Such repeatable, aseptic fluid couplingsystems are configured to facilitate multiple connection anddisconnection cycles while maintaining the sterility/isolation of thefluid pathway through the coupling system, even while the fluid couplingsystems are used in a non-sterile environment or an environment havingother types of contaminants. For example, particular embodiments ofthese fluid coupling devices can be configured to improve bioprocessingfluid handling equipment because the fluid coupling devices can berepeatably connected and disconnected (e.g., multiple times) in asterile, aseptic fashion. In the context of this disclosure, the term“fluid” includes both gases and liquids.

The fluid coupling systems provided herein can be further described asbeing configured to allow fluid transmission through the coupling in amanner that isolates the coupling's fluid flow path from regions outsideof the fluid flow path. That is the case whether the coupling's fluidflow path is, at the time of initial use, sterile/aseptic or not. Hence,when a material is transmitted through the fluid flow path of thecoupling, the material is protected/isolated from potential contaminants(including, but not limited to, microorganisms) from regions outside ofthe fluid flow path. In addition, the coupling portions of the fluidcoupling systems provided herein can be disconnected and reconnectedmultiple times while maintaining the isolation of the coupling's fluidflow path (and the isolation of the material within the fluid flowpath).

While the fluid coupling systems provided herein are generally referredto as sterile/aseptic fluid coupling systems, it should be understoodthat the fluid coupling systems can be used in a sterilized statusand/or in a nonsterile status. When the fluid coupling systems aresterilized prior to the initial use, the coupling will maintain thesterility of sterile fluids transmitted through the coupling. In otherwords, the fluid coupling systems isolate a sterile fluid from anon-sterile environment while transmitting the sterile fluid through thecoupling. Or, if a nonsterile fluid is being transmitted through thecoupling, the fluid coupling system will isolate the nonsterile fluidfrom the environment outside of the coupling's fluid flow path. Hence,the fluid coupling systems provided herein are configured to isolatefluid flowing through the coupling from the surrounding environment(including, but not limited to, isolation from microorganisms), and toconsistently maintain that isolation even while the coupling isconnected and disconnected multiple times.

In one implementation, an aseptic fluid coupling system includes a firstcoupling portion and a second coupling portion configured to releasablycouple with the first coupling portion. The first coupling portionincludes a first valve body defining a first longitudinal axis and afirst end port, a first valve member disposed within the first valvebody, and a cap that is releasably coupleable to the first valve body.The cap encloses at least a portion of the first valve body while thecap is coupled to the first valve body. The second coupling portionincludes a housing, a second valve body coupled with the housing (thesecond valve body defining a second longitudinal axis and a second endport), a second valve member disposed within the second valve body, anda connection member configured to releasably couple with the firstcoupling portion. The connection member is movably coupled with thehousing between a first position and a second position.

Such an aseptic fluid coupling system may optionally include one or moreof the following features. The second valve body may be slidably coupledwith the housing. The second valve body may be slidable along the secondlongitudinal axis. The connection member may be slidably coupled withthe housing. The connection member may be slidable between the firstposition and the second position along a path that is transverse to thesecond longitudinal axis. In some embodiments, while the connectionmember is in the second position, the connection member may be coaxialwith the second longitudinal axis. In some embodiments, while the firstcoupling portion is coupled to the connection member, the firstlongitudinal axis is coincident with the second longitudinal axis. Inparticular embodiments, while the connection member is in the firstposition and the first coupling portion is coupled to the connectionmember, the first longitudinal axis may be spaced apart from the secondlongitudinal axis. The first longitudinal axis may be parallel to thesecond longitudinal axis. The cap may be releasably coupleable to thefirst valve body using a bayonet connection. In some embodiments, whilethe cap is coupled to the first valve body, a first seal exists betweenthe cap and the first valve body, and the first seal may be configuredto maintain sterility of a first sterile space enclosed within the capand adjacent to the first valve member. In various embodiments, whilethe cap is uncoupled from the first valve body after the first couplingportion is coupled with the connection member, the sterility of thefirst sterile space is maintained. The second coupling portion may besealed so as to maintain sterility of a second sterile space adjacent tothe second valve member. In some embodiments, while the connectionmember is in the second position, the first sterile space is in fluidcommunication with the second sterile space. In particular embodiments,while the connection member is in the second position, the second valvebody may be slidable along the second longitudinal axis such that thefirst valve member can become engaged with the second valve member tothereby open a fluid pathway between the first and second end ports. Thefluid pathway may be a sterile fluid pathway. The aseptic fluid couplingsystem may further comprise a flexible member coupled to the housing andto the connection member. The flexible member may reconfigure while theconnection member is moved between the first position and the secondposition. The flexible member may be configured to maintain a sterileseal of the second coupling portion while the connection member is movedbetween the first position and the second position. In some embodiments,while: (i) the first coupling portion is coupled with the connectionmember, (ii) the connection member is in the first position, and (iii)the cap is coupled with the first valve body, the connection member maybe prevented from moving toward the second position. In variousembodiments, while: (i) the first coupling portion is coupled with theconnection member and (ii) the connection member is in the firstposition, the cap can be uncoupled from the first valve body by a capmovement comprising a translation of the cap along the firstlongitudinal axis. The cap movement may further comprise a rotation ofthe cap about the first longitudinal axis prior to the translation ofthe cap along the first longitudinal axis. In some embodiments, while:(i) the first coupling portion is coupled with the connection member,(ii) the connection member is in the first position, and (iii) the capis uncoupled with the first valve body, the connection member may befree to move toward the second position. In particular embodiments,while: (i) the first coupling portion is coupled with the connectionmember and (ii) the connection member is in the second position, thefirst longitudinal axis is coincident with the second longitudinal axis,and a fluid flow path from the first end port to the second end port canbe opened by a displacement of the second valve body in relation to thehousing and toward the first valve body.

In another implementation, an aseptic fluid coupling system includes afirst coupling portion and a second coupling portion configured toreleasably couple with the first coupling portion. The first couplingportion includes a first valve body defining a first longitudinal axisand a first end port, a first valve member disposed within the firstvalve body, and a cap that is releasably coupleable to the first valvebody. The second coupling portion includes a housing, a second valvebody coupled with the housing (the second valve body defining a secondlongitudinal axis and a second end port), a second valve member disposedwithin the second valve body, and a connection member configured toreleasably couple with the first coupling portion. The connection memberis slidably coupled with the housing and slidable in relation to thehousing between a first position and a second position. While the firstcoupling portion is coupled with the connection member, the firstcoupling portion is positionable in a first position where the firstlongitudinal axis is spaced apart from the second longitudinal axis anda second position where the first longitudinal axis is coincident withthe second longitudinal axis.

Such an aseptic fluid coupling system may optionally include one or moreof the following features. The second valve body may be slidably coupledwith the housing. The second valve body may be slidable along the secondlongitudinal axis. The connection member may be slidable between thefirst position and the second position along a path that is transverseto the second longitudinal axis. The first longitudinal axis may beparallel to the second longitudinal axis. The cap may be releasablycoupleable to the first valve body by a bayonet connection. In someembodiments, while the cap is coupled to the first valve body, a firstseal exists between the cap and the first valve body. The first seal maybe configured to maintain sterility of a first sterile space enclosedwithin the cap and adjacent to the first valve member. In variousembodiments, while the cap is uncoupled from the first valve body afterthe first coupling portion is coupled with the connection member, thesterility of the first sterile space is maintained. The second couplingportion may be sealed so as to maintain sterility of a second sterilespace adjacent to the second valve member. In some embodiments, whilethe connection member is in the second position, the first sterile spaceis in fluid communication with the second sterile space. In particularembodiments, while the connection member is in the second position, thesecond valve body is slidable along the second longitudinal axis suchthat the first valve member can become engaged with the second valvemember to thereby open a fluid pathway between the first and second endports. The fluid pathway may be a sterile fluid pathway. The asepticfluid coupling system may further comprise a flexible member coupled tothe housing and to the connection member. The flexible member may beconfigured to flex while the connection member is moved between thefirst position and the second position. The flexible member may beconfigured to maintain a sterile seal of the second coupling portionwhile the connection member is moved between the first position and thesecond position. In some embodiments, while: (i) the first couplingportion is coupled with the connection member, (ii) the connectionmember is in the first position, and (iii) the cap is coupled with thefirst valve body, the connection member may be prevented from movingtoward the second position. In various embodiments, while: (i) the firstcoupling portion is coupled with the connection member and (ii) the capis uncoupled from the first valve body, the connection member may beslidable orthogonally in relation to the second longitudinal axisbetween the first position and the second position. In particularembodiments, while: (i) the first coupling portion is coupled with theconnection member and (ii) the connection member is in the firstposition, the cap may be uncoupleable from the first valve body by a capmovement comprising a translation of the cap along the firstlongitudinal axis. The cap movement may further comprise a rotation ofthe cap about the first longitudinal axis prior to the translation ofthe cap along the first longitudinal axis.

In another implementation, an aseptic fluid coupling system comprises afirst coupling portion and a second coupling portion to releasablycouple with the first coupling portion. The first coupling portionincludes a first valve body defining a first longitudinal axis and afirst end port, a first valve member disposed within the first valvebody, and a cap that is releasably coupleable to the first valve body.The cap encloses at least a portion of the first valve body while thecap is coupled to the first valve body. The second coupling portionincludes a housing, a second valve body coupled with the housing, thesecond valve body defining a second longitudinal axis and a second endport, a second valve member disposed within the second valve body, and aconnection member configured to releasably couple with the firstcoupling portion. While the first coupling portion is coupled with theconnection member, the cap can by uncoupled from the first valve body bya cap movement comprising a translation of the cap along the firstlongitudinal axis.

Such an aseptic fluid coupling system may optionally include one or moreof the following features. The cap movement may further comprise arotation of the cap about the first longitudinal axis prior to thetranslation of the cap along the first longitudinal axis. The firstvalve member may be movable between (i) an open position that allowsfluid flow through the first valve body and (ii) a closed position thatblocks fluid flow through the first valve body. The first valve membermay be spring-biased to be located in the closed position. The secondvalve member may be movable between (i) an open position that allowsfluid flow through the second valve body and (ii) a closed position thatblocks fluid flow through the second valve body. The second valve membermay be spring-biased to be located in the closed position. The secondvalve body may be slidably coupled with the housing. The second valvebody may be slidable along the second longitudinal axis. The connectionmember may be slidably coupled with the housing. The connection membermay be slidable between the first position and the second position alonga path that is transverse to the second longitudinal axis. In someembodiments, while the connection member is in the second position, theconnection member may be coaxial with the second longitudinal axis. Invarious embodiments, while the first coupling portion is coupled to theconnection member, the first longitudinal axis is coincident with thesecond longitudinal axis. In particular embodiments, while theconnection member is in the first position and the first couplingportion is coupled to the connection member, the first longitudinal axismay be spaced apart from the second longitudinal axis. The firstlongitudinal axis may be parallel to the second longitudinal axis. Thecap may be releasably coupleable to the first valve body using a bayonetconnection. In some embodiments, while the cap is coupled to the firstvalve body, a first seal exists between the cap and the first valvebody. The first seal may be configured to maintain sterility of a firststerile space enclosed within the cap and adjacent to the first valvemember. In various embodiments, while the cap is uncoupled from thefirst valve body after the first coupling portion is coupled with theconnection member, the sterility of the first sterile space may bemaintained. The second coupling portion may be sealed so as to maintainsterility of a second sterile space adjacent to the second valve member.In some embodiments, while the connection member is in the secondposition, the first sterile space is in fluid communication with thesecond sterile space. In particular embodiments, while the connectionmember is in the second position, the second valve body may be slidablealong the second longitudinal axis such that the first valve member canbecome engaged with the second valve member to thereby open a fluidpathway between the first and second end ports. The fluid pathway may bea sterile fluid pathway. The aseptic fluid coupling system may furthercomprise a flexible member coupled to the housing and to the connectionmember. The flexible member may reconfigure while the connection memberis moved between the first position and the second position. Theflexible member may be configured to maintain a sterile seal of thesecond coupling portion while the connection member is moved between thefirst position and the second position. In some embodiments, while: (i)the first coupling portion is coupled with the connection member, (ii)the connection member is in the first position, and (iii) the cap iscoupled with the first valve body, the connection member is preventedfrom moving toward the second position. In various embodiments, while:(i) the first coupling portion is coupled with the connection member,(ii) the connection member is in the first position, and (iii) the capis uncoupled with the first valve body, the connection member may befree to move toward the second position. In particular embodiments,while: (i) the first coupling portion is coupled with the connectionmember and (ii) the connection member is in the second position, thefirst longitudinal axis may be coincident with the second longitudinalaxis, and a fluid flow path from the first end port to the second endport can be opened by a displacement of the second valve body inrelation to the housing and toward the first valve body.

In another implementation, a method of using a reusable, aseptic fluidcoupling system includes connecting a first coupling portion of theaseptic fluid coupling system to a second coupling portion of theaseptic fluid coupling system, moving the connection member (with thefirst coupling portion coupled thereto) to a second position in relationto the housing, and engaging the first valve member with the secondvalve member to open a fluid pathway between the first and second endports. The first coupling portion can include: (i) a first valve bodydefining a first longitudinal axis and a first end port; (ii) a firstvalve member disposed within the first valve body; and (iii) a cap thatis releasably coupled to the first valve body. The second couplingportion can include: (a) a housing; (b) a second valve body coupled withthe housing, the second valve body defining a second longitudinal axisand a second end port; (c) a second valve member disposed within thesecond valve body; and (d) a connection member releasably coupled withthe first coupling portion and disposed at a first position in relationto the housing.

Such a method of using a reusable, aseptic fluid coupling system mayoptionally include one or more of the following features. The firstvalve member and the second valve member may be each sterile, and thefluid pathway may be a sterile fluid pathway. The method may alsoinclude, after opening the sterile fluid pathway, disengaging the firstvalve member from the second valve member to close the fluid pathwaybetween the first and second end ports. The method may also include,after disengaging the first valve member from the second valve member,disconnecting the first coupling portion from the second couplingportion, wherein the first valve member and the second valve member eachremain sterile. The method may also include, after disconnecting thefirst coupling portion from the second coupling portion, reconnectingthe first coupling portion to the second coupling portion and re-openingthe sterile fluid pathway, wherein the first valve member and the secondvalve member each remain sterile.

In another implementation, a fluid coupling device includes a firstcoupling portion and a second coupling portion. The first couplingportion includes a first valve body defining a first longitudinal axisand a first end port, and a cap that is releasably coupleable to thefirst valve body. The second coupling portion includes a housing, asecond valve body coupled with the housing (the second valve bodydefining a second longitudinal axis and a second end port), and aconnection member configured to releasably couple with the firstcoupling portion. The connection member is movably coupled with thehousing between a first position in which the first and secondlongitudinal axes are dissimilar from each other and a second positionin which the first and second longitudinal axes are coincident.

In another implementation, an aseptic fluid coupling system includes afirst coupling portion, a second coupling portion that is releasablycoupleable with the first coupling portion, and a middle couplingportion configured to releasably connect with the first coupling portionand with the second coupling portion. The first coupling portionincludes a first valve body defining a first end port, a first valvemember disposed within the first valve body, and a first cap that isreleasably coupleable to the first valve body. The first cap encloses atleast a portion of the first valve body while the first cap is coupledto the first valve body. The second coupling portion includes a secondvalve body defining a second end port, a second valve member disposedwithin the second valve body (the second valve member being engageablewith the first valve member such that, while the first valve member andthe second valve member are engaged, a fluid flow path is open betweenthe first end port and the second end port), and a second cap that isreleasably coupleable to the second valve body. The second cap enclosesat least a portion of the second valve body while the second cap iscoupled to the second valve body. The middle coupling portion defines anenclosure. The middle coupling portion is configured such that, whilethe first coupling portion and the second coupling portion are connectedto the middle coupling portion, the first coupling portion and thesecond coupling portion can be coupled to each other within theenclosure.

Such an aseptic fluid coupling system may optionally include one or moreof the following features. The middle coupling portion may furthercomprise a first cap trap and a second cap trap. The first cap trap maybe releasably coupleable with the first cap and the second cap trap isreleasably coupleable with the second cap. The first cap trap and thesecond cap trap may be disposed within the enclosure. In someembodiments, while the first coupling portion and the second couplingportion are coupled to each other within the enclosure, the first captrap is coupled to the first cap and the second cap trap is coupled tothe second cap. The first cap trap coupled to the first cap and thesecond cap trap coupled to the second cap may be each loosely containedwithin the enclosure.

In another implementation, an aseptic fluid coupling system includes afirst coupling portion and a second coupling portion that is configuredto releasably couple with the first coupling portion. The first couplingportion includes a first valve body defining a first end port and afirst longitudinal axis, a first valve member disposed within the firstvalve body, and a first cap that is releasably coupleable to the firstvalve body. The first cap encloses at least a portion of the first valvebody while the first cap is coupled to the first valve body. The secondcoupling portion includes an inner housing defining a second end port(the inner housing configured to releasably couple with the first cap),a second valve member coupled to the inner housing and defining a secondlongitudinal axis (the second valve member configured to releasablyengage with the first valve member), and an outer housing that isrotatable and translatable in relation to the inner housing. The outerhousing includes a connection structure that is configured to releasablycouple with the first valve body. The connection structure defines athird longitudinal axis.

Such an aseptic fluid coupling system may optionally include one or moreof the following features. The first coupling portion may be coupleablewith the second coupling portion such that the first longitudinal axisand the third longitudinal axis are coincident and spaced apart from thesecond longitudinal axis. In some embodiments, while the first couplingportion is coupled with the second coupling portion, the inner housingis longitudinally translatable in relation to the outer housing.Longitudinal translation of the inner housing in relation to the outerhousing may cause the cap to uncouple from the first valve body. Invarious embodiments, while the cap is uncoupled from the first valvebody, the inner housing may be rotatable in relation to the outerhousing such that the first longitudinal axis can be aligned coincidentwith the second longitudinal axis. In some embodiments, while the firstlongitudinal axis is aligned coincident with the second longitudinalaxis, the first valve member can be engaged with the second valve memberto establish a fluid pathway between the first end port and the secondend port. The fluid pathway may be a sterile fluid pathway.

In another implementation, an aseptic fluid coupling system includes afirst means for coupling to a first portion of a fluid line and a secondmeans for coupling to a second portion of the fluid line and forrepeatably connecting and disconnecting with the first means in asterile, aseptic manner.

Particular embodiments of the subject matter described in this documentcan be implemented to realize one or more of the following advantages.First, in some embodiments the fluid coupling systems provided hereinare configured to allow fluid flow therethrough in a sterile/isolatedmanner. Moreover, in some embodiments the fluid coupling systemsprovided herein are configured to allow multiple connection anddisconnection cycles while maintaining the sterility/isolation of thefluid pathway through the coupling system, even while the fluid couplingsystems are used in a non-sterile environment and/or in an environmentcontaining materials considered as contaminants in relation to the fluidflowing through the coupling.

Second, in some embodiments the fluid coupling systems are configured toprevent undesired or improper movements during the coupling and/ordecoupling processes of the fluid coupling portions. For example, insome embodiments the fluid coupling systems include physical featuresthat preclude a user from implementing actions that are inconsistentwith the proper process for coupling the portions of the fluid couplingsystems to establish a sterile fluid pathway therethrough.

Third, in some embodiments, the fluid coupling systems mayadvantageously provide a user with audible and/or tactile feedback inreference to the motions performed for physically connecting anddisconnecting the two portions of the fluid coupling systems from eachother. Such audible and/or tactile feedback can provide the user with anefficient and conclusive indication or confirmation of the properfunction and desired configuration of the fluid coupling systems.

Fourth, some embodiments of the fluid coupling systems provide animproved aseptic connection and disconnection capability that mayoptionally reduce or eliminate the need for sterile rooms or sterilebenchtop environments in some cases. As such, these embodiments of theaseptic fluid coupling systems described herein may facilitate efficientand cost-effective operations or uses that would otherwise be high-costor even cost prohibitive in some traditional settings that required thedisconnection of particular fluid couplings in a sterile room or withina sterile flow-hood to prevent biological contamination.

Fifth, some embodiments of the fluid coupling devices provided hereinare advantageously designed with a robust locking system. That is, whenthe two halves of the coupling system are operably connected with eachother, they are also mechanically locked together. In some embodiments,to release the lock, two latches on the coupling must be simultaneouslydepressed. This redundant requirement (e.g., simultaneous actuation oftwo latches or other actuators) for unlocking the coupling portions mayreduce the likelihood of unintentional disconnections (and theassociated potential for unintentional contamination of the fluidflowing through the fluid coupling device).

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this disclosure pertains. In addition, the materials,methods, and examples of the embodiments described herein areillustrative only and not intended to be limiting.

The details of one or more embodiments of the invention are set forth inthe accompanying drawings and the description herein. Other features,objects, and advantages of the invention will be apparent from thedescription and drawings, and from the claims.

DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a fluid coupling device, in accordancewith some embodiments provided herein.

FIG. 2 is a longitudinal side view of the fluid coupling device of FIG.1.

FIG. 3 is a longitudinal cross-section view of the fluid coupling deviceof FIG. 1.

FIG. 4 is a perspective view of a cap that mates with the fluid couplingdevice of FIG. 1, in accordance with some embodiments provided herein.

FIG. 5 is a longitudinal side view of the cap of FIG. 4.

FIG. 6 is a longitudinal cross-sectional view of the cap of FIG. 4.

FIG. 7 is an exploded perspective view of the fluid coupling device ofFIG. 1 and the cap of FIG. 4.

FIG. 8 is an exploded longitudinal side view of the fluid couplingdevice of FIG. 1 and the cap of FIG. 4.

FIG. 9 is an exploded longitudinal cross-sectional view of the fluidcoupling device of FIG. 1 and the cap of FIG. 4.

FIG. 10 is a perspective view of the fluid coupling device of FIG. 1coupled with the cap of FIG. 4 to form a first fluid coupling portion ofa repeatable sterile fluid coupling system in accordance with someembodiments.

FIG. 11 is a longitudinal side view of the fluid coupling portion ofFIG. 10.

FIG. 12 is a longitudinal cross-sectional side view of the fluidcoupling portion of FIG. 10.

FIG. 13 is a perspective view of a second fluid coupling portion of arepeatable sterile fluid coupling, in accordance with some embodiments.

FIG. 14 is a longitudinal side view of the fluid coupling portion ofFIG. 13.

FIG. 15 is a longitudinal cross-sectional side view of the fluidcoupling portion of FIG. 13.

FIG. 16 is an exploded perspective view of a repeatable sterile fluidcoupling system, in accordance with some embodiments. The illustratedrepeatable sterile fluid coupling includes the first fluid couplingportion of FIG. 10 and the second fluid coupling portion of FIG. 13.

FIG. 17 is an exploded longitudinal side view of the repeatable sterilefluid coupling system of FIG. 16.

FIG. 18 is an exploded longitudinal cross-section side view of therepeatable sterile fluid coupling system of FIG. 16.

FIG. 19 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 16 in a first configuration.

FIG. 20 is a longitudinal side view of the repeatable sterile fluidcoupling system as configured in FIG. 19.

FIG. 21 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system as configured in FIG. 19.

FIG. 22 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 16 in a second configuration.

FIG. 23 is a longitudinal side view of the repeatable sterile fluidcoupling system as configured in FIG. 22.

FIG. 24 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system as configured in FIG. 22.

FIG. 25 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 16 in a third configuration.

FIG. 26 is a longitudinal side view of the repeatable sterile fluidcoupling system as configured in FIG. 25.

FIG. 27 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system as configured in FIG. 25.

FIG. 28 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 16 in a fourth configuration. A fluid flow path existsthrough the repeatable sterile fluid coupling system in the fourthconfiguration.

FIG. 29 is a longitudinal side view of the repeatable sterile fluidcoupling system as configured in FIG. 28.

FIG. 30 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system as configured in FIG. 28.

FIG. 31 is a perspective view of another example repeatable sterilefluid coupling system in accordance with some embodiments. Therepeatable sterile fluid coupling system is in an uncoupledconfiguration.

FIG. 32 is a side view of the repeatable sterile fluid coupling systemof FIG. 31 in a coupled configuration.

FIG. 33 is an exploded perspective view of another example repeatablesterile fluid coupling system in accordance with some embodiments.

FIG. 34 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 33 in a first configuration.

FIG. 35 is a partial perspective view of the repeatable sterile fluidcoupling system of FIG. 33 in a second configuration.

FIG. 36 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system of FIG. 33 in the second configuration.

FIG. 37 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 33 in a third configuration.

FIG. 38 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 33 in a fourth configuration.

FIG. 39 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system of FIG. 33 in the fourth configuration.

FIG. 40 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system of FIG. 33 in a fifth configuration.

FIG. 41 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 33 in the fifth configuration.

FIG. 42 is a perspective view of another fluid coupling device, inaccordance with some embodiments provided herein.

FIG. 43 is a longitudinal side view of the fluid coupling device of FIG.42.

FIG. 44 is a longitudinal cross-section view of the fluid couplingdevice of FIG. 42.

FIG. 45 is a perspective view of a cap that mates with the fluidcoupling device of FIG. 42, in accordance with some embodiments providedherein.

FIG. 46 is a longitudinal side view of the cap of FIG. 45.

FIG. 47 is a longitudinal cross-sectional view of the cap of FIG. 45.

FIG. 48 is an exploded perspective view of the fluid coupling device ofFIG. 42 and the cap of FIG. 45.

FIG. 49 is an exploded longitudinal side view of the fluid couplingdevice of FIG. 42 and the cap of FIG. 45.

FIG. 50 is an exploded longitudinal cross-sectional view of the fluidcoupling device of FIG. 42 and the cap of FIG. 45.

FIG. 51 is a perspective view of the fluid coupling device of FIG. 42coupled with the cap of FIG. 45 to form a first fluid coupling portionof a repeatable sterile fluid coupling system in accordance with someembodiments.

FIG. 52 is a longitudinal side view of the fluid coupling portion ofFIG. 51.

FIG. 53 is a longitudinal cross-sectional side view of the fluidcoupling portion of FIG. 51.

FIG. 54 is a perspective view of a second fluid coupling portion of arepeatable sterile fluid coupling, in accordance with some embodiments.

FIG. 55 is a longitudinal side view of the fluid coupling portion ofFIG. 54.

FIG. 56 is a longitudinal cross-sectional side view of the fluidcoupling portion of FIG. 54.

FIG. 57 is an exploded perspective view of a repeatable sterile fluidcoupling system, in accordance with some embodiments. The illustratedrepeatable sterile fluid coupling includes the first fluid couplingportion of FIG. 51 and the second fluid coupling portion of FIG. 54.

FIG. 58 is an exploded longitudinal side view of the repeatable sterilefluid coupling system of FIG. 57.

FIG. 59 is an exploded longitudinal cross-section side view of therepeatable sterile fluid coupling system of FIG. 57.

FIG. 60 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 57 in a first configuration.

FIG. 61 is a longitudinal side view of the repeatable sterile fluidcoupling system as configured in FIG. 60.

FIG. 62 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system as configured in FIG. 60.

FIG. 63 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 57 in a second configuration.

FIG. 64 is a longitudinal side view of the repeatable sterile fluidcoupling system as configured in FIG. 63.

FIG. 65 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system as configured in FIG. 63.

FIG. 66 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 57 in a third configuration.

FIG. 67 is a longitudinal side view of the repeatable sterile fluidcoupling system as configured in FIG. 66.

FIG. 68 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system as configured in FIG. 66.

FIG. 69 is a perspective view of the repeatable sterile fluid couplingsystem of FIG. 57 in a fourth configuration. A fluid flow path existsthrough the repeatable sterile fluid coupling system in the fourthconfiguration.

FIG. 70 is a longitudinal side view of the repeatable sterile fluidcoupling system as configured in FIG. 69.

FIG. 71 is a longitudinal cross-sectional side view of the repeatablesterile fluid coupling system as configured in FIG. 69.

FIG. 72 is a perspective view of a repeatable sterile fluid couplingsystem that includes a cycle counter mechanism in accordance with someembodiments.

Like reference numbers represent corresponding parts throughout.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

Referring to FIGS. 1-3, some embodiments of a reusable aseptic fluidcoupling system include a fluid coupling device 100. As describedfurther below, the fluid coupling device 100 may be releasablycoupleable with a cap that protects the sterility/isolation of the fluidflow path within the fluid coupling device 100 prior to mating the fluidcoupling device 100 with another fluid coupling.

In the depicted embodiment, the fluid coupling device 100 includes avalve body 110, a valve member 120, and a connection structure 130. Thevalve member 120 is movably coupled in relation to the valve body 110.The connection structure 130 is coupled to the valve body 110, and insome embodiments the connection structure 130 is movably coupled inrelation to the valve body 110.

In the depicted embodiment, the valve body 110 includes an end portion112 that defines an end port 114. The end portion 112 may be configuredfor connecting the fluid coupling device 100 to another element of afluid system, such as a tube, container, valve, fitting, and other typesof fluid system components. Accordingly, end portion 112 may includevarious configurations such as, but not limited to, a barbed fitting (asshown), a luer fitting, a compression fitting, a threaded fitting(internal or external), a sanitary fitting, a pigtail, a T-fitting, aY-fitting, a bag fitment, and any other suitable type of configurationsuch that the fluid coupling device 100 is suitable for connection to afluid system as desired. In some embodiments, the fluid coupling device100 may be supplied with a removable cap (not shown), or another type ofcomponent, that is releasably coupled with the end portion 112, and thatcovers end port 114.

The valve body 110 defines a fluid pathway 116 that terminates at theend port 114. In the depicted embodiment, the patency of the fluidpathway 116 is determined by the position of the valve member 120 inrelation to the valve body 110. That is, the valve member 120 can movein relation to the valve body 110 to open the fluid pathway 116 throughthe fluid coupling device 100, or to close the fluid pathway 116 throughthe fluid coupling device 100. In the illustrated, non-limitingconfiguration, the valve member 120 can translate along a longitudinalaxis 102 defined by the valve body 110. In some embodiments, thelongitudinal axis 102 is coaxial with the fluid pathway 116, but such anarrangement is not required in all embodiments.

In the illustrated arrangement, the valve member 120 is positioned in aclosed position in which the valve member 120 provides a fluidic-sealedocclusion of the fluid pathway 116. A spring member 122 is included, inthe depicted embodiment, to bias the valve member 120 to the closedposition. A peripheral elastomeric seal 124 (e.g., an o-ring) isincluded such that the fluid pathway 116 is sealed closed while thevalve member 120 is in the closed position.

As described further below, in some embodiments the valve member 120 canbe engaged by another valve member to force the valve member 120 to movein relation to the valve body 110 (e.g., toward the end portion 114),and to thereby open the fluid pathway 116 through fluid coupling device100.

In the depicted embodiment, the valve member 120 is a poppet valve. Insome embodiments, other types of valve members 120 are alternatively oradditionally used in the valve body 110. For example, in someembodiments the valve member 120 is a type of valve such as, but notlimited to, a butterfly valve, a ball valve, a duckbill valve, adiaphragm valve, a needle valve, a pinch valve, a plug valve, and thelike.

In some embodiments, the materials from which one or more of thecomponents of the fluid coupling device 100 are made of includethermoplastics. In particular embodiments, the materials from which thecomponents of the fluid coupling device 100 are made of arethermoplastics, such as, but not limited to, polycarbonate, polysulfone,polyether ether ketone, polysulphide, polyester, polyvinylidene fluoride(PVDF), polyethylene, polyphenylsulfone (PPSU; e.g., Radel®),polyetherimide (PEI; e.g., Ultem®), polypropylene, polyphenylene,polyaryletherketone, and the like, and combinations thereof. In someembodiments, the materials from which one or more of the components ofthe fluid coupling device 100 are made of include metals such as, butnot limited to stainless steel. In some embodiments, the fluid couplingdevice 100 is metallic-free. That is, in some embodiments no metallicmaterials are included in the fluid coupling device 100. For example, insome embodiments no metallic springs are included in the fluid couplingdevice 100. Alternatively, in some embodiments the spring member 122 isa metallic spring (e.g., spring steel, stainless steel, and the like).In some embodiments, the seals (e.g., seal 124 et al.) are made ofmaterials such as, but not limited to, silicone, fluoroelastomers (FKM),ethylene propylene diene monomer (EPDM), and the like.

As described further below, in some embodiments portions of the fluidcoupling device 100 are sterile, while other portions of the fluidcoupling device 100 are non-sterile. For example, in some embodiments atleast valve member 120 and fluid pathway 116 are sterile, whereas atleast some other portions of the fluid coupling device 100 (e.g.,connection structure 130) are non-sterile.

Referring also to FIGS. 4-6, a cap 200 can be configured to releasablycouple with the fluid coupling device 100. The cap 200 includes a firstend 210, a second end 220, and a cap body 230 therebetween. In thedepicted embodiment, an optional vent 236 is included.

The first end 210 can be configured to releasably couple (e.g., mate orengage) with the fluid coupling device 100. For example, in the depictedembodiment the first end 210 includes a bore 212 that is configured toreceive a portion of the valve body 110, and to releasably couple withthe valve body 110. In the depicted embodiment, the first end 210 andthe valve body 110 are configured for interconnection using abayonet-style coupling arrangement. The bayonet-style couplingarrangement includes one or more radial projections 111 on the valvebody 110 that are releasably engageable with one or more complementaryslots defined in the bore 212 of the cap 200. The one or morecomplementary slots defined in the bore 212 are L-shaped so that theprocess of engaging the one or more radial projections 111 within theslots includes a relative longitudinal movement followed by a relativerotational movement (i.e., a push-together motion and a turn-to-latchmotion). The rotational movement is typically about a ¼ turn or less,but may be more than a ¼ turn in some embodiments. The bayonet-stylecoupling arrangement can include a detention aspect that provides apositive lock between the fluid coupling device 100 and the cap 200 whenfully mated together. In some embodiments, other types ofinterconnections can be used such as, but not limited to, threadedconnections, detent pin connections, latches, hinges, and the like, andcombinations thereof.

In the depicted embodiment, the second end 220 is configured forconvenient manual manipulation. That is, in the depicted embodiment thesecond end 220 includes surface contours that facilitate manual grippingand manipulations such as turning, pulling, pushing, and the like. Insome embodiments, other types of features may be additionally oralternatively included to facilitate convenient manual gripping andmanipulations of cap 200. Such features may include, but are not limitedto, knurling, stippling, other types of texturing, flexible elastomericinserts, and the like, and combinations thereof.

In some embodiments, such as the depicted embodiment, the cap 200includes features that configure the cap 200 to restrictively mate withanother coupling portion in one or more desired relative orientations(as described further below). For example, in the depicted embodimentthe cap 200 includes slots 232 a and 232 b. The slots 232 a and 232 bare configured to receive one or more projections of the other couplingportion, and to thereby restrict the relative movements between the cap200 and the other coupling portion to only particular relative movementsas desired (e.g., like a key and keyway arrangement). In someembodiments, other features can be included on the cap 200 to achievethe purpose of restrictively mating with another coupling portion in oneor more desired relative orientations. For example, in some embodimentsfeatures such as, but not limited to, gear teeth, splines, threads,compression fits, and the like, and combinations thereof can be includedas part of the cap 200.

In the depicted embodiment, the cap 200 also includes the seal member234. The seal member 234 surrounds the outer periphery of the cap body230, and projects at least slightly proud therefrom. As describedfurther below, the seal member 234 is configured to seal with a portionof another coupling portion, and to maintain the sterility of sterileportions of fluid coupling device 100 and/or the isolation of portionsof the fluid coupling device 100 as desired.

The cap 200 can also include the optional vent 236 in some embodiments.The vent 236 provides an air-transmissible pathway between the bore 212and the regions exterior of the cap 200. In some embodiments, a filtermedia or porous element is included within the vent 236. Such a filteror porous element can serve to inhibit transmission of particles and/ormicroorganisms, while still allowing transmission of air therethrough.In some embodiments, the filter media or porous element of the vent 236allows the transmission of materials that are smaller than about 0.2 μmin size, while inhibiting the transmission of materials that are larger.In some embodiments, the filter media or porous element of the vent 236inhibits the transmission of materials that are larger than about 0.1μm, or about 0.3 μm, or about 0.4 μm, or about 0.5 μm, or larger than0.5 μm, while allowing the transmission of materials that are smaller.

The cap 200 can be constructed of any of the materials described abovein reference to fluid coupling device 100.

Referring to FIGS. 7-12, the fluid coupling device 100 and the cap 200are configured to releasably couple with each other to become anassembled first coupling portion 300. In the coupled configuration ofthe first coupling portion 300, at least the portion of the valve body110 that houses the valve member 120 is received in the bore 212 of thecap 200.

In some implementations, the assembled coupling portion 300 (and theother coupling portions described herein) is sterilized prior to use(e.g., using any suitable sterilization method such as gammasterilization, ethylene oxide sterilization, e-beam sterilization,Noxilizer™ sterilization, Revox® sterilization, or using an autoclave,and the like). In some cases during the sterilization, a cap (not shown)may be included on the end portion 112 to seal the end port 114 (and,hence, the fluid pathway 116). In some cases the assembled couplingportion 300 may be coupled with tubing and/or other components prior tosterilization, and the assembly is sterilized in the coupledconfiguration. After sterilization, the cap 200 maintains the sterilityof the portions of the fluid coupling device 100 that are within thebore 212, and of the fluid pathway 116. The sterility is maintained,while the cap 200 is coupled with the fluid coupling device 100, atleast in part because of a gasket 126 and/or an optional seal 128located between the cap 200 and the valve body 110. Hence, even whilethe sterilized coupling portion 300 is exposed to a non-sterileenvironment, the cap 200 can serve to maintain the sterility of theportions of the fluid coupling device 100 that will contact a fluidbeing transmitted through the fluid coupling device 100 (in the mannerdescribed further below).

In the depicted embodiment, the coupling mechanism between the cap 200and the fluid coupling device 100 is a bayonet-style connection. In someembodiments, other types of coupling mechanisms are used such as, butnot limited to, threaded connections, press-fit connections, latchconnections, cam-lock connections, over-center connections, and thelike, and combinations thereof.

Referring to FIGS. 13-15, a second coupling portion 400 can beconfigured to releasably mate with the first coupling portion 300described above. As described further below, the coupling portions 300and 400 provide a repeatably connectable aseptic fluid coupling system.In other words, the coupling portions 300 and 400 (when previouslysterilized) can be connected to establish a sterile fluid flow paththerethrough, and coupling portions 300 and 400 can thereafter bedisconnected and reconnected multiple times such that the sterile fluidflow path is repeatably established. That sterile fluid flow path can berepeatably established through the coupling portions 300 and 400 eventhough the coupling portions 300 and 400 are disconnected andreconnected multiple times in a non-sterile environment.

In the depicted embodiment, the second coupling portion 400 includes ahousing 410, a connection member 420, a sleeve 430, a flexible member440, a valve body 450, and a valve member 460. The housing 410 defines afirst longitudinal axis 402 and a second longitudinal axis 404. In thedepicted embodiment, the first longitudinal axis 402 is parallel withthe second longitudinal axis 404. The parallelism between the axes 402and 404 is not required in all embodiments.

The connection member 420 can be movably coupled with the housing 410.In the depicted embodiment, the connection member 420 is slidablycoupled with the housing 410. In particular (as described furtherbelow), the connection member 420 can translate laterally between afirst position (as shown) that is coaxial with the first longitudinalaxis 402 and a second position (e.g., FIGS. 25-30) that is coaxial withthe second longitudinal axis 404. The connection member 420 cantranslate along a path that is transverse to one or both of the axes 402and 404. In the depicted embodiment, the connection member 420 cantranslate along a path that is orthogonal to the axes 402 and 404.

The connection member 420 includes a connection structure 422 that isconfigured to releasably mate with the connection structure 130 of thefluid coupling device 100 (e.g., FIGS. 1-3). In the depicted embodiment,connection structures 130 and 422 are threaded members that canreleasably mate with each other. In some embodiments, the connectionstructures 130 and 422 include other types of connection mechanisms suchas, but not limited to, a snap connection, a thumb latch connection, abayonet-style connection, a luer connection, a luer-lock connection, andthe like, and combinations thereof.

The connection member 420 defines a connection member bore 424. In thedepicted embodiment, the sleeve 430 is located within the connectionmember bore 424. The sleeve 430 is slidably engageable within theconnection member 420. While the sleeve 430 is engaged with theconnection member 420 (as shown), the sleeve 430 mechanically interfereswith the connection member 420 such that the connection member 420cannot move from the first position (as shown) that is coaxial with thefirst longitudinal axis 402.

As described further below, the sleeve 430 can be moved away from theconnection member 420 such that the sleeve 430 becomes disengaged fromthe connection member 420. For example, in the depicted embodiment thesleeve 430 can be slidably translated (to the left in FIG. 15) along thefirst longitudinal axis 402 away from the connection member 420. Whenthe sleeve 430 has been disengaged from the connection member 420, insome embodiments the connection member 420 is free to be moved from thefirst position that is coaxial with the first longitudinal axis 402toward the second position that is coaxial with the second longitudinalaxis 404.

The sleeve 430 defines a sleeve bore 432. The sleeve bore 432 can beconfigured to receive the cap 200 (FIGS. 4-12). The sleeve 430 caninclude features to releasably mate with the cap 200. For example, inthe depicted embodiment the sleeve 430 includes a first projection 434 aand a second projection 434 b that extend within the sleeve bore 432.The first projection 434 a and the second projection 434 b canreleasably mate with the slots 232 a and 232 b of the cap 200. While inthe depicted embodiment projections and slots are used as the featureswhereby the sleeve 430 and the cap 200 can releasably mate with eachother, in some embodiments other types of features can be included. Suchfeatures can include, but are not limited to, threads, snap-togetherconnections, bayonet-style connections, compression connections, and thelike, and combinations thereof.

The sleeve 430 may include one or more seals. For example, in thedepicted embodiment the sleeve 430 includes a first seal 436 that canslidably engage with the bore 424 of the connection member 420 and/orthe housing 410, and a second seal 438 that slidably engages with thehousing 410. The seals 436 and 438 can extend around the entireperiphery of the sleeve 430. As described further below, the seals 436and 438 can provide sterility barriers and/or isolation barriers betweensterile areas/surfaces and non-sterile areas/surfaces.

The second coupling portion 400 can also include the flexible member440. The flexible member 440 acts as a seal that provides asterility/isolation barrier between particular regions interior to thecoupling portion 400, and regions external to the coupling portion 400.Moreover, the flexible member 440 provides the seal while accommodatingthe aforementioned movement of the connection member 420 in relation tothe housing 410. Accordingly, at least some portions of the flexiblemember 440 are extendable and contractible to accommodate the movementof the connection member 420. In some embodiments, the flexible member440 is elastic or otherwise reconfigurable such that the flexible member440 stretches to accommodate the movement of the connection member 420.In some embodiments, the flexible member 440 may include folds, pleats,bellows, spring members, and the like, to help accommodate the movementof the connection member 420.

In the depicted embodiment, the flexible member 440 includes an outerperiphery 442 and an inner periphery 444. The outer periphery 442 isaffixed to the housing 410. The inner periphery 444 is affixed to theconnection member 420.

The flexible member 440 can be made of any suitable material. Forexample, the flexible member 440 can be made of materials such as, butnot limited to, silicone, ePTFE, EPDM, urethane, fluorosilicone,neoprene, nitrile, latex, and the like, and combinations thereof.

The second coupling portion 400 can also include the valve body 450 thathouses the valve member 460. The valve body 450 includes an end portion452 that defines an end port 454. As with the end portion 112 describedabove, end portion 452 can be configured for any suitable type ofconnection. Accordingly, end portion 452 may have various configurationssuch as, but not limited to, a barbed fitting (as shown), a luerfitting, a compression fitting, a threaded fitting (internal orexternal), a sanitary fitting, a pigtail, a T-fitting, a Y-fitting, abag fitment, and any other suitable type of configuration such that thecoupling portion 400 is suitable for connection to a fluid system asdesired. In some embodiments, the second coupling portion 400 may besupplied with a removable cap (not shown) that is releasably coupledwith the end portion 452, and that covers end port 454.

The valve body 450 defines a fluid pathway 456 that terminates at theend port 454. In the depicted embodiment, the patency of the fluidpathway 456 is determined by the positions of the components of thevalve member 460 in relation to the valve body 450. That is, thecomponents of the valve member 460 can move in relation to the valvebody 450 to open the fluid pathway 456 through the second couplingportion 400, or to close the fluid pathway 456 through the secondcoupling portion 400. In the depicted arrangement of the components ofthe valve member 460, the fluid pathway 456 is occluded by the valvemember 460. As described further below, while the connection member 420is coaxial with the second longitudinal axis 404, and while the firstcoupling portion 300 and the second coupling portion 400 are matedtogether, the valve member 460 can engage with the valve member 120(FIG. 3) to open a fluid pathway between end ports 114 and 454. In thatmanner a sterile fluid pathway can be established through both of thefirst coupling portion 300 and the second coupling portion 400, whilethe coupling portions 300 and 400 are mated together.

In the depicted embodiment, the valve member 460 includes a center stem462, a spring-loaded movable valve sleeve 464, and a spring 469. In theillustrated arrangement, the valve member 460 is oriented in a closedposition in which the valve member 460 provides a fluidic-sealedocclusion of the fluid pathway 456. The valve sleeve 464 can be forcedaway from the end of the center stem 462 (i.e., to the left in FIG. 15)to allow fluid flow past the valve member 460. The spring member 469 isincluded, in the depicted embodiment, to bias the movable valve sleeve464 to the closed position. Peripheral elastomeric seals 466, 467, and468 (e.g., o-rings) are included such that the fluid pathway 456 issealed closed while the valve member 460 is in the closed orientation.

In the depicted embodiment, the valve member 460 is a poppet valve. Insome embodiments, other types of valve members 460 are alternatively oradditionally used in the valve body 450. For example, in someembodiments the valve member 460 is a type of valve such as, but notlimited to, a butterfly valve, a ball valve, a duckbill valve, adiaphragm valve, a needle valve, a pinch valve, a plug valve, and thelike.

In some embodiments, the valve body 450 is movable in relation to thehousing 410. In the depicted embodiment, the valve body 450 can beslidably translated along the second longitudinal axis 404. For example,in the depicted embodiment the valve body 450 can be slidably translated(to the right in FIG. 15) along the first longitudinal axis 402generally toward the connection member 420.

In the depicted embodiment, the valve body 450 is physically prevented(blocked) from being translated longitudinally toward the connectionmember 420 unless the connector member 420 is coaxial with the valvebody 450. That is, unless the connection member 420 is in its secondposition (coaxial with the second longitudinal axis 404), the valve body450 cannot move from its position as shown in FIG. 15.

The valve body 450 may include one or more seals. For example, in thedepicted embodiment the valve body 450 includes a seal 458 that canslidably engage with the housing 410. The seal 458 can extend around theentire periphery of the valve body 450. As described further below, theseal 458 can provide sterility/isolation barriers between sterileareas/surfaces and non-sterile areas/surfaces.

In some embodiments, the materials from which the components of thesecond coupling portion 400 are made of include thermoplastics. Inparticular embodiments, the materials from which the components of thesecond coupling portion 400 are made of are thermoplastics, such as, butnot limited to, polycarbonate, polysulfone, polyether ether ketone,polysulphide, polyester, polyphenylene, polyaryletherketone, and thelike, and combinations thereof. In some embodiments, the second couplingportion 400 is metallic-free. That is, in some embodiments no metallicmaterials are included in the second coupling portion 400. For example,in some embodiments no metallic springs are included in the secondcoupling portion 400. Alternatively, in some embodiments the springmember 469 is a metallic spring (e.g., spring steel, stainless steel,and the like). In some embodiments, the seals (e.g., seal 436 et al.)are made of materials such as, but not limited to, silicone,fluoroelastomers (FKM), ethylene propylene diene monomer (EPDM), and thelike.

In some implementations, the assembled coupling portion 400 (and theother coupling portions described herein) is sterilized prior to use(e.g., using any suitable sterilization method such as gammasterilization, ethylene oxide sterilization, e-beam sterilization,Noxilizer™ sterilization, Revox® sterilization, or using an autoclave,and the like). In some cases during the sterilization, a cap (not shown)may be included on the end portion 452 to seal the end port 454. In somecases the assembled coupling portion 400 may be coupled with tubingand/or other components prior to sterilization, and the assembly issterilized in the coupled configuration.

As described further below, in some embodiments portions of the secondcoupling portion 400 are sterile, while other portions of the secondcoupling portion 400 are non-sterile. For example, in some embodimentsat least valve member 460 and fluid pathway 456 are sterile, whereas atleast some other portions of the second coupling portion 400 (e.g.,connection structure 422) are non-sterile.

FIGS. 16-30 illustrate a sequential process of connecting the firstcoupling portion 300 with the second coupling portion 400 so as toestablish a sterile/isolated fluid pathway therethrough (between endports 114 and 454). Thereafter, to disconnect the first coupling portion300 from the second coupling portion 400, the process can be reversed.It should be understood that the steps for the connection anddisconnection processes are described primarily in relation to aparticular example embodiment (the first coupling portion 300 with thesecond coupling portion 400), and that variations of the steps are alsoenvisioned within the scope of this disclosure.

The coupling portions 300 and 400 (and the other coupling portions ofthe other coupling embodiments described herein) are designed to befunctionally interchangeable coupling portions. For example, thecoupling portion 300 is designed such that it can be coupled with two ormore of the coupling portions 400 (at individual times), if so desired.That is, the first coupling portion 300 may be coupled with a particularsecond coupling portion 400, then uncoupled, and then coupled with adifferent second coupling portion 400, and so on for still other secondcoupling portions 400 as desired. Likewise, the second coupling portion400 may be coupled with a particular first coupling portion 300, thenuncoupled, and then coupled with a different first coupling portion 300,and so on for still other first coupling portions 300 as desired. Ineach instance of coupling and uncoupling, the isolation from thesurrounding environment of the fluids in the various coupling portions300 and 400 can be maintained.

Referring to FIGS. 16-18, the first coupling portion 300 and the secondcoupling portion 400 can be selectively mated with each other, andunmated from each other. In the depicted embodiment, the cap 200 of thefirst coupling portion 300 can be inserted into the bores 424 and 432 ofthe connection member 420 and the sleeve 430 respectively (FIG. 15). Theprojections 434 a and 434 b can be oriented in alignment with the slots232 a and 232 b (FIG. 4) to facilitate proper, full engagement betweenthe first coupling portion 300 and the second coupling portion 400. Toinitiate the process of engaging the first coupling portion 300 and thesecond coupling portion 400, the connection structures 130 and 422 canbe mated together. For example, in the depicted embodiment theconnection structure 130 is rotated in relation to the housings 110 and410 such that connection structure 130 is threaded into engagement withthe connection structure 422.

In some implementations, the first coupling portion 300 and the secondcoupling portion 400 are each sterilized prior to use. That is, at leastsome interior regions/surfaces of the first coupling portion 300 and thesecond coupling portion 400 are sterile prior to mating the firstcoupling portion 300 and the second coupling portion 400 together. Asdescribed further below, the first coupling portion 300 and the secondcoupling portion 400 are configured such that the sterileregions/surfaces remain sterile throughout the processes of connectingand disconnecting the first coupling portion 300 and the second couplingportion 400.

In some implementations, the repeatable sterile fluid coupling systemmade up of the first coupling portion 300 mated with the second couplingportion 400 is configured to, for example, releasably connect a firstfluid system equipment or container to a second fluid system equipmentor container. In one non-limiting example, the repeatable sterile fluidcoupling systems described herein can provide a reusable, asepticconnection and disconnection capability for a fluid path between abioreactor system (e.g., connected directly to one coupling portion300/400, or connected via a fluid tube) and a fluid container in theform of a media bag (e.g., connected directly to the other couplingportion 300/400, or connected via a fluid tube).

Referring to FIGS. 19-21, after completing the interconnection of thefirst coupling portion 300 and the second coupling portion 400 asdescribed above, the depicted fluid coupling system 500 is arranged inthe configuration as shown. In this arrangement, the longitudinal axis102 of the first coupling portion 300 is coincident with the firstlongitudinal axis 402 of the second coupling portion 400. The seal 118provides an airtight seal between the first coupling portion 300 and thesecond coupling portion 400. The sleeve 430 is positioned so as torestrict the movement of the connection member 420 away from theposition shown (e.g., a translational movement of the connection member420 and first fluid coupling portion 300 toward the second longitudinalaxis 404).

As described above, the first coupling portion 300 and the secondcoupling portion 400 can be previously sterilized. Accordingly, thefirst coupling portion 300 can have a first sterile region 301, and thesecond coupling portion 400 can have a second sterile region 401. Thesterile regions 301 and 401 are in addition to the sterile fluidpathways 116 and 456. The first sterile region 301 includes the spacesand surfaces between the cap 200 and the fluid coupling device 100. Insome embodiments, the gasket 126 serves to seal the first sterile region301 from the other, outer surfaces of the first coupling portion 300that may be unsterile. The second sterile region 401, in general,includes the spaces and surfaces defined between the flexible member440, the connection member 420, and the housing 410.

In the configuration as shown, the cap 200 is still engaged with thefluid coupling device 100. The second end 220 of the cap 200 isprojecting out from the housing 410 of the second coupling portion 400.In this arrangement, the second end 220 is accessible to a user suchthat the cap 200 can be manipulated.

The next step in the process of coupling the first coupling portion 300with the second coupling portion 400 to create a fluid flow pathwaytherethrough is to remove the cap 200 from the fluid coupling device100. In the depicted embodiment, the cap 200 can be removed from thefluid coupling device 100 by first rotating the cap 200 and then pullingthe cap 200 off from the fluid coupling device 100 along the firstlongitudinal axis 402. As the cap 200 is rotated and then pulled (by auser of the fluid coupling system 500), the projections 434 a and 434 btravel within the slots 232 a and 232 b. The projections 434 a and 434 band slots 232 a and 232 b are configured to facilitate the desiredmovements of the cap 200 in relation to the first and second couplingportions 300/400, so as to properly remove the cap 200 from the fluidcoupling device 100. As the cap 200 is pulled away from engagement withthe fluid coupling device 100, the sleeve 430 will also travel with thecap 200.

Referring to FIGS. 22-24, after completing the disengagement of the cap200 from the fluid coupling device 100 as described above, the depictedfluid coupling system 500 is then arranged in the configuration asshown. The cap 200 and the sleeve 430 have been pulled away fromengagement with the first coupling portion 300. Consequently, the sleeve430 will no longer restrict the movement of the connection member 420away from the connection member's first position that is coaxial withthe first longitudinal axis 402. That is, with the sleeve 430 located inthe position shown, the connection member 420 and the fluid couplingdevice 100 are free to be slid towards the second position of theconnection member 420 where the connection member 420 is coaxial withthe second longitudinal axis 404. It should be understood that until theconnection member 420 is located in the second position where theconnection member 420 is coaxial with the second longitudinal axis 404,the valve body 450 is physically restricted from moving from theorientation as shown.

Referring to FIGS. 25-27, after the user moves the connection member 420and the fluid coupling device 100 to the connection member's secondposition that is coaxial with the second longitudinal axis 404, thedepicted fluid coupling system 500 is then arranged in the configurationas shown. The sterile regions 301 and 401 are now in fluid communicationwith each other.

As the connection member 420 and the fluid coupling device 100 are movedbetween the first position that is coaxial with the first longitudinalaxis 402 and the second position that is coaxial with the secondlongitudinal axis 404, the flexible member 440 conforms as needed tofacilitate the movement, while maintaining a sterile barrier and/orisolation barrier.

While the connection member 420 and the fluid coupling device 100 are inthe second position as shown, the longitudinal axis 102 of the fluidcoupling device 100 is coincident with the second longitudinal axis 404.In that arrangement, the valve member 120 of the first coupling portion300 is in alignment with the valve member 460 of the second couplingportion 400. Therefore, by moving the valve body 450 that houses thevalve member 460 toward the valve member 120 of the first couplingportion 300, the two valve members 120 and 460 can engage with eachother so that a fluid flow pathway is opened.

Referring to FIGS. 28-30, after the user moves the valve body 450 towardthe valve member 120 of the first coupling portion 300, the two valvemembers 120 and 460 engage with each other to open a fluid flow pathway,and the depicted fluid coupling system 500 is then arranged in theconfiguration as shown.

As the two valve members 120 and 460 engage with each other, the centerstem 462 of the valve member 460 makes face-to-face contact with thevalve member 120. In addition, the spring-loaded movable valve sleeve464 makes contact with a portion of the valve body 110 that surroundsthe valve member 120. Such contact results in compression of springmember 122 and of spring member 469, and a sterile/isolated fluid flowpathway is opened between the end ports 114 and 454.

In the depicted embodiment, the user can push the valve body 450 towardthe first coupling portion 300. As the valve body 450 is pushed by theuser, the spring members 122 and 469 will become compressed and provideresistance to the pushing. The valve body 450 and the housing 410 can beconfigured to allow the valve body 450 to be releasably locked inrelation to the housing 410 while the spring members 122 and 469 arecompressed. For example, in the depicted embodiment, after pushing thevalve body 450 toward the first coupling portion 300 along thelongitudinal axis 404 so as to compress the spring members 122 and 469,the user can then twist the valve body 450 to lock the valve body 450 tothe housing 410. In result, the user can release the valve body 450 andhousing 410 and the sterile fluid flow pathway will remain open betweenend ports 114 and 454. In the depicted embodiment, a bayonet-stylecoupling is used to releasably lock the valve body 450 to the housing410. In some embodiments, other types of mechanisms can be used toreleasably lock the valve body 450 to the housing 410 such as, but notlimited to, a pin/hole, a clip, a latch, a threaded connection, and thelike, and combinations thereof.

While in the depicted embodiment the two valve members 120 and 460 aremade to engage with each other by pushing the valve body 450 toward thefirst coupling portion 300, in some embodiments the engagement can bemade by pushing the first coupling portion 300 (or portions thereof)toward the valve body 450. That is, in some embodiments the valve body450 is fixed in relation to the housing 410, and the first couplingportion 300 is translatable along axes 102 and 404 when the firstcoupling portion 300 is in the second portion (where the two valvemembers 120 and 460 are coaxial).

With the fluid coupling system 500 arranged in the illustratedconfiguration, fluids can flow through the fluid coupling system 500between the end ports 114 and 454. The fluid pathway between the endports 114 and 454 is a sterile/isolated fluid pathway.

If desired, the fluid coupling system 500 can be uncoupled by followingthe reverse of the process described above for coupling the fluidcoupling system 500. As the fluid coupling system 500 is uncoupled (suchthat the first coupling portion 300 is separated from the secondcoupling portion 400), the sterility/isolation of the first sterileregion 301 and the second sterile region 401 is maintained. For example,as part of the process for separating the first coupling portion 300from the second coupling portion 400, the cap 200 is reinstalled on thefluid coupling device 100, and the coupling portions 300 and 400 areconfigured as shown in FIGS. 16-18 once again. Thereafter, if desired,the fluid coupling system 500 can be recoupled by following the processdescribed above for coupling the fluid coupling system 500. Once again,a sterile/isolated fluid pathway between the end ports 114 and 454 willbe established. One of skill in the art will recognize that therepeatable, aseptic fluid coupling system 500 can be connected,disconnected, reconnected, and so on, for multiple cycles. In each case,while the first coupling portion 300 is connected to the second couplingportion 400 as shown in FIGS. 28-30, a sterile/isolated fluid pathwaybetween the end ports 114 and 454 exists.

Referring to FIG. 31, another example fluid coupling system 600 canprovide an aseptic/isolated fluid connection that can be coupled anduncoupled multiple times. The fluid coupling system 600 includes a firstend fluid coupling portion 610, a second end fluid coupling portion 620,and a middle fluid coupling portion 630. The first end fluid couplingportion 610 can be releasably connected to a first end 632 of the middlefluid coupling portion 630, and the second end fluid coupling portion620 can be releasably connected to a second end 633 of the middle fluidcoupling portion 630. As described further below, the fluid couplingsystem 600, in its fully connected configuration (FIG. 32), establishesa sterile/isolated fluid pathway between a first end port 611 and asecond end port 621.

In some embodiments, such as the depicted embodiment, the first endfluid coupling portion 610 and the second end fluid coupling portion 620are configured the same as each other. Alternatively, in someembodiments the first end fluid coupling portion 610 and the second endfluid coupling portion 620 can be configured differently from eachother. For example, while each of the end fluid coupling portions 610and 620 are depicted as having a barbed connection 612 and 622, in someembodiments one or both of connections 612 and 622 have other types ofconfigurations such as, but not limited to, a luer fitting, acompression fitting, a threaded fitting (internal or external), asanitary fitting, a pigtail, a T-fitting, a Y-fitting, a bag fitment,and any other suitable type of configuration such that the fluidcoupling system 600 is suitable for connection to a fluid system asdesired.

In the depicted embodiment, each of the fluid coupling portions 610 and620 also include a valve body 613 and 623 respectively, a connectionstructure 614 and 624 respectively, and a cap 615 and 625 respectively.The caps 615 and 625 are selectively coupleable with the valve bodies613 and 623 respectively. In the illustration, portions of the valvebodies 613 and 623 are obscured from view by the caps 615 and 625respectively. The portion of the valve bodies 613 and 623 that areobscured from view house valve members (e.g., in some embodiments likevalve members 120 and 460 of fluid coupling system 500 described above)that are configured to engage with each other as described furtherbelow.

While not shown, it should be understood that in some embodiments eachend fluid coupling portion 610 and 620 may include a removable end cap(not shown), or another type of component, that is coupled to theconnections 612 and 622 respectively. The fluid coupling portions 610and 620 with end caps or other types of components coupled to theconnections 612 and 622 may be sterilized so that the fluid pathways andvalve members within each end fluid coupling portion 610 and 620 aresterile (in a manner analogous to that of first coupling portion 300 asdescribed above).

In some embodiments, such as the depicted embodiment, the middle fluidcoupling portion 630 includes a first cap trap 634, a second cap trap636, a first cap trap release 638, a second cap trap release 640, afirst cap release 642, and a second cap release 644. The middle fluidcoupling portion 630 can also include a flexible housing 650 defining anenclosure in which the cap traps 634 and 636 are disposed.

In the depicted embodiment, the flexible housing 650 is deformable bythe manipulations of a user of the fluid coupling system 600. In someembodiments, the flexible housing 650 is configured as a bag-likemember. The material of the flexible housing 650 (or portions thereof)can be transparent or semi-transparent and flexible to allow for manualmanipulation of the components housed within the flexible housing 650.The material of the flexible housing 650 is also suitable forsterilization (e.g., gamma sterilization, autoclave, EtO, e-beam, etc.).For example, in some embodiments the material of the flexible housing650 (or portions thereof) is polyester, and other suitable materials.The ends 632 and 633 can be coupled to the flexible housing 650 so thatthe connection structures of the ends 632 and 633 are accessible on theexterior of the flexible housing 650. As described further below, theflexible housing 650 is deformable so that the user can move the ends632 and 633 toward each other to couple the fluid coupling portions 610and 620 together within the flexible housing 650.

The first cap trap release 638 can be activated to release the first captrap 634 from engagement with the first end 632. The second cap traprelease 640 can be activated to release the second cap trap 636 fromengagement with the second end 633. The first cap release 642 can beactivated to release the first cap 615 from engagement with the firstcap trap 634. The second cap release 644 can be activated to release thesecond cap 625 from engagement with the second cap trap 636.

In some embodiments, the process for connecting the fluid couplingsystem 600 to create a sterile fluid pathway between the first end port611 and the second end port 621 is as follows. The user can connect thefirst end fluid coupling portion 610 and the second end fluid couplingportion 620 to the first end 632 and the second end 633 of the middlefluid coupling portion 630 respectively (or, in some embodiments, in theopposite relationship if so desired). In doing so, the caps 615 and 625become releasably locked inside of the first cap trap 634 and the secondcap trap 636 respectively. Then, the user can manipulate the first captrap release 638 and the first cap trap 634 through the flexible housing650 such that the first cap trap 634 (with the first cap 615 lockedtherein) becomes unlocked and removed from the first end 632. The firstcap trap 634 (with the first cap 615 locked therein) can be released bythe user and allowed to remain loose within the flexible housing 650.Next, the user can manipulate the second cap trap release 640 and thesecond cap 636 through the flexible housing 650 such that the second captrap 636 (with the second cap 625 locked therein) becomes unlocked andremoved from the second end 633. The second cap trap 636 (with thesecond cap 625 locked therein) can be released by the user and allowedto remain loose within the flexible housing 650.

By removing the caps 615 and 625, the sterile portions of the first endfluid coupling portion 610 and the second end fluid coupling portion 620are exposed within the sterile confines of the flexible housing 650. Forexample, the valve member contained in each of the first end fluidcoupling portion 610 and the second end fluid coupling portion 620 areexposed within the sterile confines of the flexible housing 650.

Referring also to FIG. 32, with the valve members of the couplingportions 610 and 620 exposed to each other within the sterile confinesof the flexible housing 650, the user can move the first end fluidcoupling portion 610 and the second end fluid coupling portion 620toward each other and can couple the valve members together. Theflexible housing 640 can flex and/or act like an accordion member toaccommodate the movement of the coupling portions 610 and 620 into acoupled arrangement. With the coupling portions 610 and 620 in thecoupled arrangement, a sterile fluid pathway between first end port 611and second end port 621 of the fluid coupling system 600 is established.In some embodiments, the first cap trap 634 (with the first cap 615locked therein) and the second cap trap 636 (with the second cap 625locked therein) can remain loosely contained within the flexible housing650. In some embodiments, the first cap trap 634 (with the first cap 615locked therein) and the second cap trap 636 (with the second cap 625locked therein) can be releasably coupled with respective receptacleslocated within the flexible housing 650 rather than being looselycontained therein. For example, posts (not shown) within the flexiblehousing 650 can be provided within the flexible housing 650 with whichthe first cap trap 634 (with the first cap 615 locked therein) and thesecond cap trap 636 (with the second cap 625 locked therein) can beengaged. Hence, in some embodiments the first cap trap 634 (with thefirst cap 615 locked therein) and the second cap trap 636 (with thesecond cap 625 locked therein) can be rigidly contained within theflexible housing 650.

To uncouple the fluid coupling system 600 from coupled arrangement shownin FIG. 32, the user can perform the following process steps. First, theuser can uncouple the valve members of the coupling portions 610 and620. Next, the user can engage the first cap trap 634 (with the firstcap 615 locked therein) onto the first end fluid coupling portion 610and the second cap trap 636 (with the second cap 625 locked therein)onto the second end fluid coupling portion 620. Next, the user canactivate the first cap release 642 and then uncouple the firstconnection structure 614 from the first end 632 of the middle fluidcoupling portion 630 (to attain the arrangement shown in FIG. 31).Likewise, the user can activate the second cap release 644 and thenuncouple the second connection structure 624 from the second end 633 ofthe middle fluid coupling portion 630 (to attain the arrangement shownin FIG. 31). The caps 615 and 625 maintain the sterility of the sterileportions of the coupling portions 610 and 620 (e.g., the valve members).The cap traps 634 and 636 maintain the sterility of the sterile portionsof the middle fluid coupling portion 630 (e.g., the interior surfaces ofthe flexible housing 650 and the exterior surfaces of the cap traps 634and 636). Thereafter, the user can reconnect the components of the fluidcoupling system 600 to reestablish a sterile fluid pathway between firstend port 611 and second end port 621 if so desired.

One of skill in the art will recognize that the repeatable, asepticfluid coupling system 600 can be connected, disconnected, reconnected,and so on, for multiple cycles. In each case, while the couplingportions 610 and 620 are connected within the middle fluid couplingportion 630 as shown in FIG. 32, a sterile/isolated fluid pathwaybetween the end ports 611 and 621 exists.

Referring to FIG. 33, another example fluid coupling system 700 canprovide an aseptic/isolated fluid connection that can be coupled anduncoupled for multiple cycles. The fluid coupling system 700 includes afirst coupling portion 710 and a second coupling portion 750. The firstcoupling portion 710 can be releasably connected to the second couplingportion 750. In some implementations, prior to connecting the firstcoupling portion 710 to the second coupling portion 750, the couplingportions 710 and 750 are sterilized such that some inner regions andsurfaces of the coupling portions 710 and 750 are sterile. As describedfurther below, the fluid coupling system 700, in its fully connectedconfiguration (FIGS. 40 and 41), can establish a sterile/isolated fluidpathway between a first end port 711 and a second end port 751.

In some embodiments, the first coupling portion 710 is configured withat least some of the same types of structural features as the firstcoupling portion 300 described above. For example, in the depictedembodiment the first coupling portion 710 includes an end portion 712, avalve body 714, a connection structure 716, and a cap 720, which areanalogous to structural features of the first coupling portion 300.Therefore, structural features of the first coupling portion 710 can beany of the different types and variations of the analogous structuralfeatures described above regarding the first coupling portion 300. Thematerials of construction of the first coupling portion 710 can be anyof the materials described above regarding the first coupling portion300. As with the cap 200 of the first coupling portion 300, the cap 720is removably coupled to the valve body 714.

The valve body 714 houses a first valve member 718 (not visible in thisview; refer to FIG. 36) that, in some embodiments, can be analogous tovalve member 120 described above. The first coupling portion 710includes the connection structure 716 that is configured to selectivelymate with a complementary connection structure of the second couplingportion 750. The first coupling portion 710 defines a longitudinal axis702.

In the depicted embodiment, the second coupling portion 750 includes aninner housing portion 753 and an outer housing portion 754. As describedfurther below, the inner housing portion 753 and the outer housingportion 754 are both longitudinally slidable in relation to each other,and rotatable in relation to each other. In particular, inner housingportion 753 and the outer housing portion 754 are rotatable in relationto each other about a central axis 706. The relative rotation and thelongitudinal elongation between inner housing portion 753 and the outerhousing portion 754 are releasably retained by a first latch 758 a and asecond latch 758 b.

The second coupling portion 750 includes an end portion 752 and a valvebody 756 that define a longitudinal axis 704. The valve body 756 housesa second valve member 757 (not visible in this view; refer to FIG. 36)that, in some embodiments, can be analogous to valve member 460described above. The second coupling portion 750 includes the connectionstructure 760 that is configured to selectively mate with thecomplementary connection structure 716 of the first coupling portion710.

The second coupling portion 750 includes a port 755 in which the firstcoupling portion 710 can be releasably received. The port 755 defines alongitudinal axis 705. When the first coupling portion 710 is engaged inthe port 755 of the second coupling portion 750, the longitudinal axis702 is coincident with the longitudinal axis 705.

In some embodiments, the materials from which the components of thefluid coupling system 700 are made of include thermoplastics. Inparticular embodiments, the materials from which the components of thefluid coupling system 700 are made of are thermoplastics, such as, butnot limited to, polycarbonate, polysulfone, polyether ether ketone,polysulphide, polyester, polyvinylidene fluoride (PVDF), polyethylene,polyphenylsulfone (PPSU; e.g., Radel®), polyetherimide (PEI; e.g.,Ultem®), polypropylene, polyphenylene, polyaryletherketone, and thelike, and combinations thereof. In some embodiments, the materials fromwhich one or more of the components of the fluid coupling system 700 aremade of include metals such as, but not limited to stainless steel. Insome embodiments, the fluid coupling system 700 is metallic-free. Thatis, in some embodiments no metallic materials are included in the fluidcoupling system 700. For example, in some embodiments no metallicsprings are included in the fluid coupling system 700. Alternatively, insome embodiments the spring member(s) is a metallic spring (e.g., springsteel, stainless steel, and the like). In some embodiments, the sealsand/or gaskets are made of materials such as, but not limited to,silicone, fluoroelastomers (FKM), ethylene propylene diene monomer(EPDM), and the like.

FIGS. 34-41 illustrate a sequential process of connecting the firstcoupling portion 710 with the second coupling portion 750 so as toestablish a sterile fluid pathway therethrough (between end ports 711and 751). Thereafter, to disconnect the first coupling portion 710 fromthe second coupling portion 750, the process can be reversed. It shouldbe understood that the steps for the connection and disconnectionprocesses are described primarily in relation to a particular exampleembodiment (the first coupling portion 710 with the second couplingportion 750), and that variations of the steps are also envisionedwithin the scope of this disclosure.

Referring to FIGS. 34 and 35, a user of the fluid coupling system 700can releasably engage the first coupling portion 710 with the secondcoupling portion 750. For example, a structural feature, such as aprotrusion 721 on the cap 720, can be used to releasably engage thefirst coupling portion 710 with the second coupling portion 750. In thedepicted embodiment, the protrusion 721 is mateable with a complementarystructural feature 759 of the inner housing portion 753. In thisexample, the first coupling portion 710 can be releasably engaged withthe second coupling portion 750 by pushing the first coupling portion710 into engagement with the second coupling portion 750, and thenrotating the first coupling portion 710 in relation to the secondcoupling portion 750. In doing so, the protrusion 721 on the cap 720will become releasably engaged with the complementary structural feature759 of the inner housing portion 753, resulting in engagement of thefirst coupling portion 710 with the second coupling portion 750.

FIG. 36 provides a longitudinal cross-sectional view of the fluidcoupling system 700 with the first coupling portion 710 in engagementwith the second coupling portion 750. The valve members 718 and 757 ofthe first coupling portion 710 and the second coupling portion 750respectively are visible. It can be seen that the valve members 718 and757 are unaligned in relation to each other in the depictedconfiguration.

As described above, the first coupling portion 710 and the secondcoupling portion 750 can be previously sterilized. Accordingly, thefirst coupling portion 710 can have a first sterile region 724, and thesecond coupling portion 750 can have a second sterile region 764. Thesterile regions 724 and 764 are sterile areas in addition to sterilefluid pathways 707 and 708. The first sterile region 724 includes thespaces and surfaces between the cap 720 and the valve body 714. Thesecond sterile region 764, in general, includes the spaces and surfacesadjacent to the face of the second valve member 757. One or more sealsand/or gaskets can be included to separate the sterile regions 724 and764 from other regions that may be unsterile.

In the depicted embodiment, the first coupling portion 710 and thesecond coupling portion 750 include optional vents 722 and 762respectively. Such vents may be included in any of the fluid couplingsystem embodiments described herein. The material of the vents 722 and762 may allow for air/gas transmission while preventing through-flow(e.g., ingress) of bacteria and/or other contaminants. The material ofthe vents 722 and 762 can be porous and configured to allow thetransmission of materials that are smaller than about 0.2 μm in size,while inhibiting the transmission of materials that are larger. In someembodiments, the filter media or porous element of the vents 722 and 762inhibits the transmission of materials that are larger than about 0.1μm, or about 0.3 μm, or about 0.4 μm, or about 0.5 μm, or larger than0.5 μm, while allowing the transmission of materials that are smaller.

As with the fluid coupling system 500 described above, the fluidcoupling system 700 includes multiple seals and/or gaskets that act asbarriers to isolate inner sterile regions of the fluid coupling system700 from other unsterile regions, and/or as fluid flow seals.

Referring to FIG. 37, a user of the fluid coupling system 700 canlongitudinally translate the inner housing portion 753 in relation tothe outer housing portion 754. In essence, the longitudinal translationof the inner housing portion 753 in relation to the outer housingportion 754 is similar to a telescoping movement. Prior to performingthe longitudinal translation, the user will deactivate any latch orcoupling mechanism(s) between the inner housing portion 753 and theouter housing portion 754. For example, in the depicted embodiment, theuser would deactivate the latches 758 a and 758 b. With the latches 758a and 758 b decoupled from the inner housing portion 753, the user canthen pull the inner housing portion 753 in relation to the outer housingportion 754 to result in the depicted configuration. Built in structuraltravel-stop features serve to limit the longitudinal elongation of thefluid coupling system 700.

As the inner housing portion 753 is longitudinally translated inrelation to the outer housing portion 754, the cap 720 becomes removedand longitudinally separated from the rest of the first coupling portion710.

Referring to FIGS. 38 and 39, the next step in the process of connectingthe first coupling portion 710 with the second coupling portion 750 soas to establish a sterile fluid pathway between end ports 711 and 751 isfor the user to rotate the inner housing portion 753 in relation to theouter housing portion 754 about the central axis 706. In the depictedembodiment, the user rotates the inner housing portion 753 in relationto the outer housing portion 754 by about 180°. In some embodiments, thefluid coupling system 700 may be configured such that other amounts ofrotation between the housing portions 753 and 754 (e.g., about 90°,about 120°, about 150°, and the like) are used in preparation forestablishing a sterile fluid pathway between end ports 711 and 751. Insome embodiments, built in structural travel-stop features serve tolimit the relative rotational movements of the inner housing portion 753in relation to the outer housing portion 754. In the depictedembodiment, after the rotation of the inner housing portion 753 inrelation to the outer housing portion 754, the latches 758 a and 758 bbecome longitudinally realigned with mating members (e.g., notches, andthe like) of the inner housing portion 753 in preparation forre-latching the inner housing portion 753 in relation to the outerhousing portion 754.

Completion of the rotation of the inner housing portion 753 in relationto the outer housing portion 754 causes the longitudinal axis 702 tobecome coincident with the longitudinal axis 704. In other words, therotation results in the valve members 718 and 757 becoming positionedand oriented in longitudinal alignment with each other. The sterileregions 724 and 764 are now in fluid communication with each other.

Referring to FIGS. 40 and 41, the next step in the process of connectingthe first coupling portion 710 with the second coupling portion 750 soas to establish a sterile fluid pathway between end ports 711 and 751 isfor the user to longitudinally compress the inner housing portion 753 inrelation to the outer housing portion 754.

As the fluid coupling system 700 is longitudinally compressed by theuser, the spring members of the valve members 718 and 757 will becomecompressed and provide resistance to the compression. The inner housingportion 753 and the outer housing portion 754 can be configured to allowthe fluid coupling system 700 to be releasably locked while the springmembers of the valve members 718 and 757 are compressed. For example, inthe depicted embodiment, after compressing the inner housing portion 753and the outer housing portion 754 toward each other, the latches 758 aand 758 b can lock the fluid coupling system 700 in the compressedconfiguration. In result, the user can release the fluid coupling system700 and the sterile fluid flow pathway will remain open between endports 711 and 751. In some embodiments, other types of mechanisms can beused to releasably lock the inner housing portion 753 in relation to theouter housing portion 754 such as, but not limited to, a pin/hole, aclip, a bayonet-style connection, a threaded connection, and the like,and combinations thereof.

With the fluid coupling system 700 arranged in the illustratedconfiguration, fluids can flow through the fluid coupling system 700between the end ports 711 and 751. The fluid pathway between the endports 711 and 751 is a sterile fluid pathway.

It should be understood that, to stop fluid flow between the end ports711 and 751, the user can simply unlatch the latches 758 a and 758 b andelongate the fluid coupling system 700 to attain the configuration ofFIGS. 38 and 39 (such that valve members 718 and 757 are no longerengaged with each other). No rotation of inner housing portion 753relative to the outer housing portion 754 is required in order tointerrupt the fluid pathway between the end ports 711 and 751 (unlessthe user wants to fully uncouple the first coupling portion 710 from thesecond coupling portion 750). Thereafter, the fluid pathway between theend ports 711 and 751 can be reestablished by compressing the innerhousing portion 753 and the outer housing portion 754 toward each other.Again, the latches 758 a and 758 b can lock the fluid coupling system700 in the compressed configuration.

If desired, the fluid coupling system 700 can be fully uncoupled byfollowing the reverse of the process described above for coupling thefluid coupling system 700. As the fluid coupling system 700 is uncoupled(such that the first coupling portion 710 is separated from the secondcoupling portion 750), the sterility/isolation of the first sterileregion 724 and the second sterile region 764 is maintained. For example,as part of the process for separating the first coupling portion 710from the second coupling portion 750, the cap 720 is reinstalled on thefirst coupling portion 710, and the coupling portions 710 and 750 areconfigured as shown in FIG. 33 once again. Thereafter, if desired, thefluid coupling system 700 can be recoupled by following the processdescribed above for coupling the fluid coupling system 700. Once again,a sterile fluid pathway between the end ports 711 and 751 will beestablished. One of skill in the art will recognize that the repeatable,aseptic fluid coupling system 700 can be connected, disconnected,reconnected, and so on, for multiple cycles. In each case, while thefirst coupling portion 710 is connected to the second coupling portion750, and the fluid coupling system 700 is configured as shown in FIGS.40-41, a sterile/isolated fluid pathway between the end ports 711 and751 exists.

Referring to FIGS. 42-44, some embodiments of a reusable aseptic fluidcoupling system include a fluid coupling device 800 (which is alsoreferred to herein as an insert 800). As described further below, theinsert 800 may be releasably coupleable with a cap that protects thesterility/isolation of the fluid flow path within the insert 800 priorto mating the insert 800 with another fluid coupling.

In the depicted embodiment, the insert 800 includes a valve body 810, avalve member 820, and a connection structure 830. The valve member 820is movably coupled in relation to the valve body 810. The connectionstructure 830 is coupled to the valve body 810.

In the depicted embodiment, the valve body 810 includes an end portion812 that defines an end port 814. The end portion 812 may be configuredfor connecting the insert 800 to another element of a fluid system, suchas a tube, container, valve, fitting, and other types of fluid systemcomponents. Accordingly, end portion 812 may include variousconfigurations such as, but not limited to, a barbed fitting (as shown),a luer fitting, a compression fitting, a threaded fitting (internal orexternal), a sanitary fitting, a pigtail, a T-fitting, a Y-fitting, abag fitment, and any other suitable type of configuration such that theinsert 800 is suitable for connection to a fluid system as desired. Insome embodiments, the insert 800 may be supplied with a removable cap(not shown), or another type of component, that is releasably coupledwith the end portion 812, and that covers end port 814.

The valve body 810 defines a fluid pathway 816 that terminates at theend port 814. In the depicted embodiment, the patency of the fluidpathway 816 is determined by the position of the valve member 820 inrelation to the valve body 810. That is, the valve member 820 can movein relation to the valve body 810 to open the fluid pathway 816 throughthe insert 800, or to close the fluid pathway 816 through the insert800. In the illustrated, non-limiting configuration, the valve member820 can translate along a longitudinal axis 802 defined by the valvebody 810. In some embodiments, the longitudinal axis 802 is coaxial withthe fluid pathway 816, but such an arrangement is not required in allembodiments.

In the illustrated arrangement, the valve member 820 is positioned in aclosed position in which the valve member 820 provides a fluidic-sealedocclusion of the fluid pathway 816. A spring member 822 is included, inthe depicted embodiment, to bias the valve member 820 to the closedposition. A peripheral elastomeric seal 824 (e.g., an o-ring or one ormore annular seals with other cross-sectional shapes such as, but notlimited to, D-shaped, polygonal, ovular, U-shaped, W-shaped, afour-lobed seal, and the like) is included such that the fluid pathway816 is sealed closed while the valve member 820 is in the closedposition.

As described further below, in some embodiments the valve member 820 canbe engaged by another valve member to force the valve member 820 to movein relation to the valve body 810 (e.g., toward the end portion 814),and to thereby open the fluid pathway 816 through the insert 800.

In the depicted embodiment, the valve member 820 is a poppet valve. Insome embodiments, other types of valve members 820 are alternatively oradditionally used in the valve body 810. For example, in someembodiments the valve member 820 is a type of valve such as, but notlimited to, a butterfly valve, a ball valve, a duckbill valve, adiaphragm valve, a needle valve, a pinch valve, a plug valve, and thelike.

As with the fluid coupling device 100 described above, the materialsfrom which one or more of the components of the insert 800 are made ofinclude thermoplastics and/or metals (see example materials describedabove in reference to the fluid coupling device 100). In someembodiments, the insert 800 is metallic-free. That is, in someembodiments no metallic materials are included in the insert 800. Forexample, in some embodiments no metallic springs are included in theinsert 800. Alternatively, in some embodiments the spring member 822 isa metallic spring (e.g., spring steel, stainless steel, and the like).In some embodiments, the seals (e.g., seal 824 et al.) are made ofmaterials such as, but not limited to, silicone, fluoroelastomers (FKM),ethylene propylene diene monomer (EPDM), and the like.

As described further below, in some embodiments portions of the insert800 are sterile, while other portions of the insert 800 are non-sterile.For example, in some embodiments at least valve member 820 and fluidpathway 816 are sterile, whereas at least some other portions of theinsert 800 (e.g., connection structure 830) are non-sterile. Moreover, acap component (as described immediately below) can be coupled with theinsert 800 and can serve to maintain the sterility of portions of theinsert 800 such as, but not limited to, the face of the valve member820.

Referring also to FIGS. 45-47, a cap 900 can be configured to releasablycouple with the insert 800. The cap 900 includes a first end 910, asecond end 920, and a cap body 930 therebetween. In the depictedembodiment, an optional vent 936 is included.

The first end 910 can be configured to releasably couple (e.g., mate orengage) with the insert 800. For example, in the depicted embodiment thefirst end 910 includes a bore 912 that is configured to receive aportion of the valve body 810, and to releasably couple with the valvebody 810. In the depicted embodiment, the first end 910 and the valvebody 810 are configured for interconnection using a bayonet-stylecoupling arrangement. The bayonet-style coupling arrangement includesone or more radial projections 811 on the valve body 810 that arereleasably engageable with one or more complementary slots 914 definedin the bore 912 of the cap 900. The one or more complementary slots 914defined in the bore 912 are L-shaped so that the process of engaging theone or more radial projections 811 within the slots includes a relativelongitudinal movement followed by a relative rotational movement (i.e.,a push-together motion and a turn-to-latch motion). The rotationalmovement is typically about a ¼ turn or less, but may be more than a ¼turn in some embodiments. The bayonet-style coupling arrangement caninclude a detention aspect that provides a positive lock between theinsert 800 and the cap 900 when fully mated together. Additionally, insome embodiments the insert 800 and the cap 900 are designed to provideaudible and/or tactile feedback to the user to confirm that the insert800 and the cap 900 are fully mated together. In some embodiments, othertypes of interconnections can be used such as, but not limited to,threaded connections, detent pin connections, latches, hinges, and thelike, and combinations thereof.

In the depicted embodiment, the second end 920 is configured forconvenient manual manipulation. That is, in the depicted embodiment thesecond end 920 includes surface contours that facilitate manual grippingand manipulations such as turning, pulling, pushing, and the like. Insome embodiments, other types of features may be additionally oralternatively included to facilitate convenient manual gripping andmanipulations of cap 900. Such features may include, but are not limitedto, knurling, stippling, other types of texturing, flexible elastomericinserts, and the like, and combinations thereof.

In some embodiments, such as the depicted embodiment, the cap 900includes features that configure the cap 900 to restrictively mate withanother coupling portion in one or more desired relative orientations(as described further below). For example, in the depicted embodimentthe cap 900 includes slots 932 a and 932 b. The slots 932 a and 932 bare configured to receive one or more projections of the other couplingportion, and to thereby restrict the relative movements between the cap900 and the other coupling portion to only particular relative movementsas desired (e.g., like a key and keyway arrangement). In someembodiments, other features can be included on the cap 900 to achievethe purpose of restrictively mating with another coupling portion in oneor more desired relative orientations. For example, in some embodimentsfeatures such as, but not limited to, gear teeth, splines, threads,compression fits, and the like, and combinations thereof can be includedas part of the cap 900.

In the depicted embodiment, the cap 900 also includes the seal member934. The seal member 934 surrounds the outer periphery of the cap body930, and projects at least slightly proud therefrom. As describedfurther below, the seal member 934 is configured to seal with a portionof another coupling portion, and to maintain the sterility of sterileportions of insert 800 and/or the isolation of portions of the insert800 as desired.

The cap 900 can also include the optional vent 936 in some embodiments.The vent 936 provides an air-transmissible pathway between the bore 912and the regions exterior of the cap 900. In some embodiments, a filtermedia or porous element is included within the vent 936. Such a filteror porous element can serve to inhibit transmission of particles and/ormicroorganisms, while still allowing transmission of air therethrough.In some embodiments, the filter media or porous element of the vent 936allows the transmission of materials that are smaller than about 0.2 μmin size, while inhibiting the transmission of materials that are larger.In some embodiments, the filter media or porous element of the vent 936inhibits the transmission of materials that are larger than about 0.1μm, or about 0.3 μm, or about 0.4 μm, or about 0.5 μm, or larger than0.5 μm, while allowing the transmission of materials that are smaller.

The cap 900 can be constructed of any of the materials described abovein reference to the insert 800.

Referring to FIGS. 48-53, the insert 800 and the cap 900 are configuredto releasably couple with each other to become an assembled firstcoupling portion 1000. In the coupled configuration of the firstcoupling portion 1000, at least the portion of the valve body 810 thathouses the valve member 820 is received in the bore 912 of the cap 900.

In some implementations, the assembled coupling portion 1000 (and theother coupling portions described herein) is sterilized prior to use(e.g., using any suitable sterilization method such as gammasterilization, ethylene oxide sterilization, e-beam sterilization,Noxilizer™ sterilization, Revox® sterilization, or using an autoclave,and the like). In some cases during the sterilization, a cap (not shown)may be included on the end portion 812 to seal the end port 814 (and,hence, the fluid pathway 816). In some cases the assembled couplingportion 1000 may be coupled with tubing and/or other components prior tosterilization, and the assembly is sterilized in the coupledconfiguration. After sterilization, the cap 900 maintains the sterilityof the portions of the insert 800 that are within the bore 912, and ofthe fluid pathway 816. The sterility is maintained, while the cap 900 iscoupled with the insert 800, at least in part because of a seal 826and/or an optional seal 828 located between the cap 900 and the valvebody 810. Hence, even while the sterilized coupling portion 1000 isexposed to a non-sterile environment, the cap 900 can serve to maintainthe sterility of the portions of the insert 800 that will contact afluid being transmitted through the insert 800 (in the manner describedfurther below).

In the depicted embodiment, the coupling mechanism between the cap 900and the insert 800 is a bayonet-style connection. In some embodiments,other types of coupling mechanisms are used such as, but not limited to,threaded connections, press-fit connections, latch connections, cam-lockconnections, over-center connections, and the like, and combinationsthereof.

Referring to FIGS. 54-56, a second coupling portion 1100 (which is alsoreferred to herein as a main body assembly 1100) can be configured toreleasably mate with the first coupling portion 1000 described above. Asdescribed further below, the coupling portions 1000 and 1100 provide arepeatably connectable aseptic fluid coupling system. In other words,the coupling portions 1000 and 1100 (when previously sterilized) can beconnected to establish a sterile fluid flow path therethrough, andcoupling portions 1000 and 1100 can thereafter be disconnected andreconnected multiple times such that the sterile fluid flow path isrepeatably established. That sterile fluid flow path can be repeatablyestablished through the coupling portions 1000 and 1100 even though thecoupling portions 1000 and 1100 are disconnected and reconnectedmultiple times in a non-sterile environment.

In the depicted embodiment, the main body assembly 1100 includes ahousing 1110, a connection member 1120 (also referred to herein as ashuttle 1120), a sleeve 1130 (also referred to herein as a slider 1130),a flexible member 1140, a body valve 1150, and a valve member 1160. Thehousing 1110 defines a first longitudinal axis 1102 and a secondlongitudinal axis 1104. In the depicted embodiment, the firstlongitudinal axis 1102 is parallel with the second longitudinal axis1104. The parallelism between the axes 1102 and 1104 is not required inall embodiments.

The shuttle 1120 can be movably coupled with the housing 1110. In thedepicted embodiment, the shuttle 1120 is slidably coupled with thehousing 1110. In particular (as described further below), the shuttle1120 can translate laterally between a first position (as shown) that iscoaxial with the first longitudinal axis 1102 and a second position(e.g., FIGS. 66-71) that is coaxial with the second longitudinal axis1104. The shuttle 1120 can translate along a path that is transverse toone or both of the axes 1102 and 1104. In the depicted embodiment, theshuttle 1120 can translate along a path that is orthogonal to the axes1102 and 1104.

The shuttle 1120 includes a connection structure 1122 that is configuredto releasably mate with the connection structure 830 of the insert 800(e.g., FIGS. 42-44). In the depicted embodiment, connection structures830 and 1122 are projections and slots, respectively, that releasablymate with each other. When the connection structures 830 and 1122 arefully coupled with each other, the coupling portions 1000 and 1100releasably latch together. Thereafter, to separate the coupling portions1000 and 1100, the user must depress a release button 1123. The releasebutton 1123 will only be actuatable if the cap 900 is properly coupledwith the insert 800. In some embodiments, the connection structures 830and 1122 include other types of connection mechanisms such as, but notlimited to, a snap connection, a thumb latch connection, a bayonet-styleconnection, a luer connection, a threaded connection, a luer-lockconnection, and the like, and combinations thereof.

The shuttle 1120 defines a connection member bore 1124. In the depictedembodiment, the slider 1130 is located within the connection member bore1124. The slider 1130 is slidably engageable within the shuttle 1120.While the slider 1130 is engaged with the shuttle 1120 (as shown), theslider 1130 mechanically interferes with the shuttle 1120 such that theshuttle 1120 cannot move from the first position (as shown) that iscoaxial with the first longitudinal axis 1102.

As described further below, the slider 1130 can be moved away from theshuttle 1120 such that the slider 1130 becomes disengaged from theshuttle 1120. For example, in the depicted embodiment the slider 1130can be slidably translated (to the left in FIG. 56) along the firstlongitudinal axis 1102 away from the shuttle 1120. When the slider 1130has been disengaged from the shuttle 1120, in some embodiments theshuttle 1120 is free to be moved from the first position that is coaxialwith the first longitudinal axis 1102 toward the second position that iscoaxial with the second longitudinal axis 1104.

The slider 1130 defines a sleeve bore 1132. The sleeve bore 1132 can beconfigured to receive the cap 900 (FIGS. 45-53). The slider 1130 caninclude features to releasably mate with the cap 900. For example, inthe depicted embodiment the slider 1130 includes a first projection 1134a and a second projection 1134 b (not visible) that extend within thesleeve bore 1132. The first projection 1134 a and the second projection1134 b can releasably mate with the slots 932 a and 932 b of the cap900. While in the depicted embodiment projections and slots are used asthe features whereby the slider 1130 and the cap 900 can releasably matewith each other, in some embodiments other types of features can beincluded. Such features can include, but are not limited to, threads,snap-together connections, bayonet-style connections, compressionconnections, and the like, and combinations thereof.

The slider 1130 may include one or more seals. For example, in thedepicted embodiment the slider 1130 includes a first seal 1136 that canslidably engage with the bore 1124 of the shuttle 1120 and/or thehousing 1110, and a second seal 1138 that slidably engages with thehousing 1110. The seals 1136 and 1138 can extend around the entireperiphery of the slider 1130. As described further below, the seals 1136and 1138 can provide sterility barriers and/or isolation barriersbetween sterile areas/surfaces and non-sterile areas/surfaces.

The main body assembly 1100 can also include the flexible member 1140.The flexible member 1140 acts as a seal that provides asterility/isolation barrier between particular regions interior to thecoupling portion 1100, and regions external to the coupling portion1100. Moreover, the flexible member 1140 provides the seal whileaccommodating the aforementioned movement of the shuttle 1120 inrelation to the housing 1110. Accordingly, at least some portions of theflexible member 1140 are extendable and contractible to accommodate themovement of the shuttle 1120. In some embodiments, the flexible member1140 is elastic or otherwise reconfigurable such that the flexiblemember 1140 stretches to accommodate the movement of the shuttle 1120.In some embodiments, the flexible member 1140 may include folds, pleats,bellows, spring members, and the like, to help accommodate the movementof the shuttle 1120.

In the depicted embodiment, the flexible member 1140 includes an outerperiphery 1142 and an inner periphery 1144. The outer periphery 1142 isaffixed to the housing 1110. The inner periphery 1144 is affixed to theshuttle 1120.

The flexible member 1140 can be made of any suitable material. Forexample, the flexible member 1140 can be made of materials such as, butnot limited to, silicone, ePTFE, EPDM, urethane, fluorosilicone,neoprene, nitrile, latex, and the like, and combinations thereof.

The main body assembly 1100 can also include the body valve 1150 thathouses the valve member 1160. The body valve 1150 includes an endportion 1152 that defines an end port 1154. As with the end portion 812described above, end portion 1152 can be configured for any suitabletype of connection. Accordingly, end portion 1152 may have variousconfigurations such as, but not limited to, a barbed fitting (as shown),a luer fitting, a compression fitting, a threaded fitting (internal orexternal), a sanitary fitting, a pigtail, a T-fitting, a Y-fitting, abag fitment, and any other suitable type of configuration such that thecoupling portion 1100 is suitable for connection to a fluid system asdesired. In some embodiments, the main body assembly 1100 may besupplied with a removable cap (not shown) that is releasably coupledwith the end portion 1152, and that covers end port 1154.

The body valve 1150 defines a fluid pathway 1156 that terminates at theend port 1154. In the depicted embodiment, the patency of the fluidpathway 1156 is determined by the positions of the components of thevalve member 1160 in relation to the body valve 1150. That is, thecomponents of the valve member 1160 can move in relation to the bodyvalve 1150 to open the fluid pathway 1156 through the main body assembly1100, or to close the fluid pathway 1156 through the main body assembly1100. In the depicted arrangement of the components of the valve member1160, the fluid pathway 1156 is occluded by the valve member 1160. Asdescribed further below, while the shuttle 1120 is coaxial with thesecond longitudinal axis 1104, and while the first coupling portion 1000and the main body assembly 1100 are mated together, the valve member1160 can engage with the valve member 820 (FIG. 44) to open a fluidpathway between end ports 814 and 1154. In that manner a sterile fluidpathway can be established through both of the first coupling portion1000 and the main body assembly 1100, while the coupling portions 1000and 1100 are mated together.

In the depicted embodiment, the valve member 1160 includes a center stem1162, a spring-loaded movable valve sleeve 1164, and a spring 1169. Inthe illustrated arrangement, the valve member 1160 is oriented in aclosed position in which the valve member 1160 provides a fluidic-sealedocclusion of the fluid pathway 1156. The valve sleeve 1164 can be forcedaway from the end of the center stem 1162 (i.e., to the left in FIG. 56)to allow fluid flow past the valve member 1160. The spring member 1169is included, in the depicted embodiment, to bias the movable valvesleeve 1164 to the closed position. Peripheral elastomeric seals 1166,1167, and 1168 (e.g., o-rings or one or more annular seals with othercross-sectional shapes such as, but not limited to, D-shaped, polygonal,ovular, U-shaped, W-shaped, a four-lobed seal, and the like) areincluded such that the fluid pathway 1156 is sealed closed while thevalve member 1160 is in the closed orientation.

In some embodiments, the valve member 1160 is a poppet valve. In someembodiments, other types of valve members 1160 are alternatively oradditionally used in the body valve 1150. For example, in someembodiments the valve member 1160 is a type of valve such as, but notlimited to, a butterfly valve, a ball valve, a duckbill valve, adiaphragm valve, a needle valve, a pinch valve, a plug valve, and thelike.

In some embodiments, the body valve 1150 is movable in relation to thehousing 1110. In the depicted embodiment, the body valve 1150 can beslidably translated along the second longitudinal axis 1104. Forexample, in the depicted embodiment the body valve 1150 can be slidablytranslated (to the right in FIG. 56) along the first longitudinal axis1102 generally toward the shuttle 1120.

In the depicted embodiment, the body valve 1150 is physically prevented(blocked) from being translated longitudinally toward the shuttle 1120unless the connector member 1120 is coaxial with the body valve 1150.That is, unless the shuttle 1120 is in its second position (coaxial withthe second longitudinal axis 1104), the body valve 1150 cannot move fromits position as shown in FIG. 56.

The body valve 1150 may include one or more seals. For example, in thedepicted embodiment the body valve 1150 includes a seal 1158 that canslidably engage with the housing 1110. The seal 1158 can extend aroundthe entire periphery of the body valve 1150. As described further below,the seal 1158 can provide sterility/isolation barriers between sterileareas/surfaces and non-sterile areas/surfaces.

As with second coupling portion 400 described above in reference toFIGS. 13-15, the materials from which the components of the main bodyassembly 1100 can be made of include thermoplastics and/or metals (seeexample materials described above in reference to the fluid couplingdevice 400). In some embodiments, the main body assembly 1100 ismetallic-free. That is, in some embodiments no metallic materials areincluded in the main body assembly 1100. For example, in someembodiments no metallic springs are included in the main body assembly1100. Alternatively, in some embodiments the spring member 1169 is ametallic spring (e.g., spring steel, stainless steel, and the like). Insome embodiments, the spring member 1169 is made of a polymericmaterial. In some embodiments, the seals (e.g., seal 1136 et al.) aremade of materials such as, but not limited to, silicone,fluoroelastomers (FKM), ethylene propylene diene monomer (EPDM), and thelike.

In some implementations, the assembled coupling portion 1100 (and theother coupling portions described herein) is sterilized prior to use(e.g., using any suitable sterilization method such as gammasterilization, ethylene oxide sterilization, e-beam sterilization,Noxilizer™ sterilization, Revox® sterilization, or using an autoclave,and the like). In some cases during the sterilization, a cap (not shown)may be included on the end portion 1152 to seal the end port 1154. Insome cases the assembled coupling portion 1100 may be coupled withtubing and/or other components prior to sterilization, and the assemblyis sterilized in the coupled configuration.

As described further below, in some embodiments portions of the mainbody assembly 1100 are sterile, while other portions of the main bodyassembly 1100 are non-sterile. For example, in some embodiments at leastvalve member 1160 and fluid pathway 1156 are sterile, whereas at leastsome other portions of the main body assembly 1100 (e.g., connectionstructure 1122) are non-sterile.

FIGS. 57-71 illustrate a sequential process of connecting the firstcoupling portion 1000 with the main body assembly 1100 so as toestablish a sterile/isolated fluid pathway therethrough (between endports 814 and 1154). Thereafter, to disconnect the first couplingportion 1000 from the main body assembly 1100, the process can bereversed. It should be understood that the steps for the connection anddisconnection processes are described primarily in relation to aparticular example embodiment (the first coupling portion 1000 with themain body assembly 1100), and that variations of the steps are alsoenvisioned within the scope of this disclosure.

The coupling portions 1000 and 1100 (and the other coupling portions ofthe other coupling embodiments described herein) are designed to befunctionally interchangeable coupling portions. For example, thecoupling portion 1000 is designed such that it can be coupled with twoor more of the coupling portions 1100 (at individual times), if sodesired. That is, the first coupling portion 1000 may be coupled with aparticular main body assembly 1100, then uncoupled, and then coupledwith a different main body assembly 1100, and so on for still othersecond coupling portions 1100 as desired. Likewise, the main bodyassembly 1100 may be coupled with a particular first coupling portion1000, then uncoupled, and then coupled with a different first couplingportion 1000, and so on for still other first coupling portions 1000 asdesired. In each instance of coupling and uncoupling, the isolation fromthe surrounding environment of the fluids in the various couplingportions 1000 and 1100 can be maintained.

Referring to FIGS. 57-59, the first coupling portion 1000 and the mainbody assembly 1100 can be selectively mated with each other, and unmatedfrom each other. In the depicted embodiment, the cap 900 of the firstcoupling portion 1000 can be inserted into the bores 1124 and 1132 ofthe shuttle 1120 and the slider 1130 respectively (FIG. 56). Theprojections 1134 a and 1134 b can be oriented in alignment with theslots 932 a and 932 b (FIG. 45) to facilitate proper, full engagementbetween the first coupling portion 1000 and the main body assembly 1100.To initiate the process of releasably coupling the first couplingportion 1000 and the main body assembly 1100, the connection structures830 and 1122 can be mated together. For example, in the depictedembodiment the connection structure 830 is aligned with the connectionstructure 1122 such that connection structure 830 is slid intoengagement with the connection structure 1122. When the first couplingportion 1000 and the main body assembly 1100 are fully engaged with eachother, a latching action between the two will result and the firstcoupling portion 1000 and the main body assembly 1100 will be releasablymated with each other. Tactile and/or audible feedback may be providedwhen the first coupling portion 1000 and the main body assembly 1100 areproperly releasably mated with each other. To decouple the firstcoupling portion 1000 from the main body assembly 1100, the user willneed to depress the release button 1123 and then separate the two. Suchdecoupling will only be possible while the cap 900 is fully engaged withthe insert 800.

In some implementations, the first coupling portion 1000 and the mainbody assembly 1100 are each sterilized prior to use. That is, at leastsome interior regions/surfaces of the first coupling portion 1000 andthe main body assembly 1100 are sterile prior to mating the firstcoupling portion 1000 and the main body assembly 1100 together. Asdescribed further below, the first coupling portion 1000 and the mainbody assembly 1100 are configured such that the sterile regions/surfacesremain sterile throughout the processes of connecting and disconnectingthe first coupling portion 1000 and the main body assembly 1100.

In some implementations, the repeatable sterile fluid coupling systemmade up of the first coupling portion 1000 mated with the main bodyassembly 1100 is configured to, for example, releasably connect a firstfluid system equipment or container to a second fluid system equipmentor container. In one non-limiting example, the repeatable sterile fluidcoupling systems described herein can provide a reusable, asepticconnection and disconnection capability for a fluid path between abioreactor system (e.g., connected directly to one coupling portion1000/1100, or connected via a fluid tube) and a fluid container in theform of a media bag (e.g., connected directly to the other couplingportion 1000/1100, or connected via a fluid tube).

Referring to FIGS. 60-62, after completing the interconnection of thefirst coupling portion 1000 and the main body assembly 1100 as describedabove, the depicted fluid coupling system 1200 is arranged in theconfiguration as shown. In this arrangement, the longitudinal axis 802of the first coupling portion 1000 is coincident with the firstlongitudinal axis 1102 of the main body assembly 1100. The seal 828provides an airtight seal between the first coupling portion 1000 andthe main body assembly 1100. The slider 1130 is positioned so as torestrict the movement of the shuttle 1120 away from the position shown(e.g., a translational movement of the shuttle 1120 and first fluidcoupling portion 1000 toward the second longitudinal axis 1104).

As described above, the first coupling portion 1000 and the main bodyassembly 1100 can be previously sterilized. Accordingly, the firstcoupling portion 1000 can have a first sterile region 1001, and the mainbody assembly 1100 can have a second sterile region 1101. The sterileregions 1001 and 1101 are in addition to the sterile fluid pathways 816and 1156. The first sterile region 1001 includes the spaces and surfacesbetween the cap 900 and the insert 800. In some embodiments, the gasket826 serves to seal the first sterile region 1001 from the other, outersurfaces of the first coupling portion 1000 that may be unsterile. Thesecond sterile region 1101, in general, includes the spaces and surfacesdefined between the flexible member 1140, the shuttle 1120, and thehousing 1110.

In the configuration as shown, the cap 900 is still engaged with theinsert 800. The second end 920 of the cap 900 is projecting out from thehousing 1110 of the main body assembly 1100. In this arrangement, thesecond end 920 is accessible to a user such that the cap 900 can bemanipulated.

The next step in the process of coupling the first coupling portion 1000with the main body assembly 1100 to create a fluid flow pathwaytherethrough is to remove the cap 900 from the insert 800. In thedepicted embodiment, the cap 900 can be removed from the insert 800 byfirst rotating the cap 900 (e.g., without limitation, about 10° to about45°, or about 20° to about 40°, or about 25° to about 35°) and thenpulling the cap 900 off from the insert 800 along the first longitudinalaxis 1102. When the cap 900 has been rotated (including both prior topulling the cap 900 off from the insert 800 and after pulling the cap900 off from the insert 800), the insert 800 is prevented from becomingseparated from the main body assembly 1100. That is, rotation of the cap900 relative to the insert 800 results in locking the insert 800 inrelation to the main body assembly 1100 so that the insert 800 cannot beremoved from engagement with the main body assembly 1100. Moreover, evenattempts to actuate the release button 1123 will not allow the insert800 to be unlocked from the main body assembly 1100.

As the cap 900 is rotated and then pulled (by a user of the fluidcoupling system 1200), the projections 1134 a and 1134 b (FIG. 56)travel within the slots 932 a and 932 b (FIG. 45). The projections 1134a and 1134 b and slots 932 a and 932 b are configured to facilitate thedesired movements of the cap 900 in relation to the first and secondcoupling portions 1000/1100, so as to properly remove the cap 900 fromthe insert 800. As the cap 900 is pulled away from engagement with theinsert 800, the slider 1130 will also travel with the cap 900.

When the cap 900 is pulled away from the insert 800 to the extent thatthe cap reaches its fully disengaged position (i.e., fully disengagedfrom the insert 800), the cap 900 can be releasably detained using adetent mechanism in that fully disengaged position. That is, the cap 900can be detained relative to the housing 1110. In some embodiments,audible and/or tactile feedback is provided to indicate that the cap 900has reached its fully disengaged position at which the cap is detainedrelative to the housing 1110.

Referring to FIGS. 63-65, after completing the disengagement of the cap900 from the insert 800 as described above, the depicted fluid couplingsystem 1200 is then arranged in the configuration as shown. The cap 900and the slider 1130 have been fully pulled away from engagement with thefirst coupling portion 1000. Consequently, the slider 1130 will nolonger restrict the movement of the shuttle 1120 away from theconnection member's first position that is coaxial with the firstlongitudinal axis 1102. That is, with the slider 1130 located in theposition shown, the shuttle 1120 and the insert 800 are free to be slidtowards the second position of the shuttle 1120 where the shuttle 1120is coaxial with the second longitudinal axis 1104. It should beunderstood that until the shuttle 1120 is located in the second positionwhere the shuttle 1120 is coaxial with the second longitudinal axis1104, the body valve 1150 is physically restricted from moving from theorientation as shown.

In some embodiments, the shuttle 1120 is releasably detained in one orboth of its end-of-travel positions (i.e., (1) positioned coaxial withthe longitudinal axis 802 and (2) positioned coaxial with the secondlongitudinal axis 1104). That is, in some embodiments as the shuttle1120 is slid into an end-of-travel position, the shuttle 1120 willbecome releasably latched into a detained relationship with the housing1110. Audible and/or tactile feedback may be provided when the shuttle1120 becomes releasably detained in its end-of-travel position(s). Insome embodiments, a mechanical unlatching (e.g., by actuating a releasemechanism) must occur to move the shuttle 1120 from a detainedend-of-travel position. Alternatively, in some embodiments merelyphysically forcing the shuttle 1120 away from a detained end-of-travelposition will forcibly overcome the detention of the shuttle 1120relative to the housing 1110.

Referring to FIGS. 66-68, after the user moves the shuttle 1120 and theinsert 800 to the connection member's second position that is coaxialwith the second longitudinal axis 1104, the depicted fluid couplingsystem 1200 is then arranged in the configuration as shown. The sterileregions 1001 and 1101 are now in fluid communication with each other.

As the shuttle 1120 and the insert 800 are moved between the firstposition that is coaxial with the first longitudinal axis 1102 and thesecond position that is coaxial with the second longitudinal axis 1104,the flexible member 1140 conforms as needed to facilitate the movement,while maintaining a sterile barrier and/or isolation barrier.

While the shuttle 1120 and the insert 800 are in the second position asshown, the longitudinal axis 802 of the insert 800 is coincident withthe second longitudinal axis 1104. In that arrangement, the valve member820 of the first coupling portion 1000 is in alignment with the valvemember 1160 of the main body assembly 1100. Therefore, by moving thebody valve 1150 that houses the valve member 1160 toward the valvemember 820 of the first coupling portion 1000, the two valve members 820and 1160 can engage with each other so that a fluid flow pathway isopened. In other words, in some embodiments valve member 820 can beopened by valve member 1160.

Referring to FIGS. 69-71, after the user moves the body valve 1150toward the valve member 820 of the first coupling portion 1000, the twovalve members 820 and 1160 engage with each other to open a fluid flowpathway, and the depicted fluid coupling system 1200 is then arranged inthe configuration as shown. Additionally, in some embodiments the bodyvalve 1150 will become releasably latched in relation to the housing1110 (when the body valve 1150 is fully engaged with the insert 800). Tothereafter unlatch the body valve 1150, in some embodiments the userwill need to depress a body valve unlatching mechanism 1125 andconcurrently pull the body valve 1150 away from the housing 1110. Insome embodiments, when the user depresses the body valve unlatchingmechanism 1125, the body valve 1150 will spontaneously move away fromthe housing 1110 (without a need for physically pulling the body valve1150 away from the housing 1110). The latching of the body valve 1150 inrelation to the housing 1110 can be accompanied by audible and/ortactile feedback to indicate that full engagement has been accomplished.

As the two valve members 820 and 1160 engage with each other, the centerstem 1162 (FIG. 56) of the valve member 1160 makes face-to-face contactwith the valve member 820. In addition, the spring-loaded movable valvesleeve 1164 makes contact with a portion of the valve body 810 thatsurrounds the valve member 820. Such contact results in compression ofspring member 822 and of spring member 1169, and a sterile/isolatedfluid flow pathway is opened between the end ports 814 and 1154.

In the depicted embodiment, the user can push the body valve 1150 towardthe first coupling portion 1000. As the body valve 1150 is pushed by theuser, the spring members 822 and 1169 will become compressed and provideresistance to the movement. The body valve 1150 and the housing 1110 canbe configured to allow the body valve 1150 to be releasably locked inrelation to the housing 1110 while the spring members 822 and 1169 arecompressed. For example, in the depicted embodiment, after pushing thebody valve 1150 toward the first coupling portion 1000 along thelongitudinal axis 1104 so as to compress the spring members 822 and1169, the user can then twist the body valve 1150 to lock the body valve1150 to the housing 1110. In result, the user can release the body valve1150 and housing 1110 and the sterile fluid flow pathway will remainopen between end ports 814 and 1154. In the depicted embodiment, abayonet-style coupling is used to releasably lock the body valve 1150 tothe housing 1110. In some embodiments, other types of mechanisms can beused to releasably lock the body valve 1150 to the housing 1110 such as,but not limited to, a pin/hole, a clip, a latch, a threaded connection,and the like, and combinations thereof.

While in the depicted embodiment the two valve members 820 and 1160 aremade to engage with each other by pushing the body valve 1150 toward thefirst coupling portion 1000, in some embodiments the engagement can bemade by pushing the first coupling portion 1000 (or portions thereof)toward the body valve 1150. That is, in some embodiments the body valve1150 is fixed in relation to the housing 1110, and the first couplingportion 1000 is translatable along axes 802 and 1104 when the firstcoupling portion 1000 is in the second portion (where the two valvemembers 820 and 1160 are coaxial).

With the fluid coupling system 1200 arranged in the illustratedconfiguration, fluids can flow through the fluid coupling system 1200between the end ports 814 and 1154. The fluid pathway between the endports 814 and 1154 is a sterile/isolated fluid pathway.

If desired, the fluid coupling system 1200 can be uncoupled by followingthe reverse of the process described above for coupling the fluidcoupling system 1200. For example, the body valve unlatching mechanism1125 can be actuated and the body valve 1150 can be concurrently pulledaway from the housing 1110. Then the shuttle 1120 (with the insert 800coupled thereto) can be translated to become coaxial with the firstlongitudinal axis 1102. At that point, the cap 900 can be pushed towardthe insert 800 and rotated into engagement with the insert 800. With thecap 900 properly engaged with the insert 800, the release button 1123can be actuated and the coupling portions 1000 and 1100 can beseparated.

As the fluid coupling system 1200 is uncoupled (such that the firstcoupling portion 1000 is separated from the main body assembly 1100),the sterility/isolation of the first sterile region 1001 and the secondsterile region 1101 is maintained. For example, as part of the processfor separating the first coupling portion 1000 from the main bodyassembly 1100, the cap 900 is reinstalled on the insert 800, and thecoupling portions 1000 and 1100 are configured as shown in FIGS. 57-59once again. Then, the release button 1123 can be depressed to unlatchthe coupling portions 1000 and 1100 from each other. The release button1123 can only be actuated effectively if the coupling portion 1000 isproperly assembled. Thereafter, if desired, the fluid coupling system1200 can be recoupled by following the process described above forcoupling the fluid coupling system 1200. Once again, a sterile/isolatedfluid pathway between the end ports 814 and 1154 will be established.One of skill in the art will recognize that the repeatable, asepticfluid coupling system 1200 can be connected, disconnected, reconnected,and so on, for multiple cycles. In each case, while the first couplingportion 1000 is connected to the main body assembly 1100 as shown inFIGS. 69-71, a sterile/isolated fluid pathway between the end ports 814and 1154 exists.

Referring to FIG. 72, in some embodiments a cycle counter 1210 isincluded in conjunction with the fluid coupling system 1200. The cyclecounter 1210 can be used to quantify a number of times that the fluidcoupling system 1200 has been operated. Moreover, in some embodiments anupper limit of permissible cycles can be selectively established, andthe cycle counter 1210 can lock-out the fluid coupling system 1200 fromfurther operation once the upper limit has been reached. The upper limitof permissible cycles can be any selected integer (e.g., 1, 2, 3, 4, 5,6, 7, 8, 9, 10, 11, 12, 13, 14, and so on).

For example, in the depicted embodiment, the cycle counter 1210 iscoupled to the housing 1110. In some embodiments, the cycle counter 1210is releasably coupled to the housing 1110. The cycle counter 1210 willbe indexed each time the shuttle 1120 is placed into its end-of-travelposition where it is coaxial with the second longitudinal axis 1104. Avisual indicator (e.g., a numeric indicator or a color indicator) of thenumber of spent cycles or the number of remaining cycles can be providedby the cycle counter 1210. Hence, the user can be informed of how manytimes the fluid coupling system 1200 has been used or how many morecycles the fluid coupling system 1200 can be used.

In some embodiments, when the upper limit of cycles have been spent, amechanism will prevent any further usage of fluid coupling system 1200.For example, in the depicted embodiment the cycle counter 1210 willmechanically interfere with the translation of the shuttle 1120 as it isbeing slid toward its end-of-travel position where it is coaxial withthe second longitudinal axis 1104. In other words, the cycle counter1210 will not permit the shuttle 1120 to be positioned at itsend-of-travel position coaxial with the second longitudinal axis 1104.Therefore, the fluid coupling system 1200 will not be further useablewhen the upper limit of usage cycles have been spent.

Similarly, in some embodiments the insert 800 can alternatively oradditionally include a cycle counter mechanism. Referring again to FIGS.42-44, an optional cycle counter mechanism 840 is movably coupled to thevalve body 810. In the depicted embodiment, the cycle counter mechanism840 is designed to be manually indexed (rotationally) prior to each use(i.e., prior to coupling the first coupling portion 1000 comprising theinsert 800 and the cap 900 to the main body assembly 1100). The cyclecounter mechanism 840 can only be rotated in one rotational direction.As with the cycle counter 1210 described above, an upper limit ofpermissible cycles can be selectively established, and the cycle countermechanism 840 can lock-out the fluid coupling system 1200 from furtheroperation once the upper limit has been reached. For example, in someembodiments when the upper limit of permissible cycles of the insert 800has been reached, the cycle counter mechanism 840 can thereaftermechanically prevent proper coupling of the first coupling portion 1000to the main body assembly 1100. Hence, the fluid coupling system 1200will not be further useable when the upper limit of usage cycles havebeen spent.

In some embodiments, the main body assembly 1100 can also include anoptional vent 1126. The vent 1126 provides an air-transmissible pathwaybetween the second sterile region 1101 and the regions exterior of themain body assembly 1100. In some embodiments, a filter media or porouselement is included within the vent 1126. Such a filter or porouselement can serve to inhibit transmission of particles and/ormicroorganisms, while still allowing transmission of air therethrough.In some embodiments, the filter media or porous element of the vent 1126allows the transmission of materials that are smaller than about 0.2 μmin size, while inhibiting the transmission of materials that are larger.In some embodiments, the filter media or porous element of the vent 1126inhibits the transmission of materials that are larger than about 0.1μm, or about 0.3 μm, or about 0.4 μm, or about 0.5 μm, or larger than0.5 μm, while allowing the transmission of materials that are smaller.

While this specification contains many specific implementation details,these should not be construed as limitations on the scope of anyinvention or of what may be claimed, but rather as descriptions offeatures that may be specific to particular embodiments of particularinventions. Certain features that are described in this specification inthe context of separate embodiments can also be implemented incombination in a single embodiment. Conversely, various features thatare described in the context of a single embodiment can also beimplemented in multiple embodiments separately or in any suitablesubcombination. Moreover, although features may be described herein asacting in certain combinations and even initially claimed as such, oneor more features from a claimed combination can in some cases be excisedfrom the combination, and the claimed combination may be directed to asubcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. In certain circumstances, multitasking and parallel processingmay be advantageous. Moreover, the separation of various system modulesand components in the embodiments described herein should not beunderstood as requiring such separation in all embodiments, and itshould be understood that the described program components and systemscan generally be integrated together in a single product or packagedinto multiple products.

Particular embodiments of the subject matter have been described. Otherembodiments are within the scope of the following claims. For example,the actions recited in the claims can be performed in a different orderand still achieve desirable results. As one example, the processesdepicted in the accompanying figures do not necessarily require theparticular order shown, or sequential order, to achieve desirableresults. In certain implementations, multitasking and parallelprocessing may be advantageous.

What is claimed is:
 1. A fluid coupling comprising: a housing defining:(i) a first longitudinal axis and (ii) a second longitudinal axis thatis parallel to the first longitudinal axis; a connection memberconfigured to releasably couple a mating coupling to the fluid coupling,the connection member movably coupled to the housing and movable betweena first position in which the connection member is coaxial with thefirst longitudinal axis and a second position in which the connectionmember is coaxial with the second longitudinal axis; a valve bodycoupled with the housing and coaxial with the second longitudinal axis,the valve body including a spring-loaded valve sleeve that is movablealong the second longitudinal axis to open and close a fluid flow paththrough the fluid coupling; and a flexible member coupled to the housingand to the connection member, wherein the flexible member reconfigureswhile the connection member is moved between the first position and thesecond position.
 2. The fluid coupling of claim 1, wherein the valvebody is slidably coupled with the housing.
 3. The fluid coupling ofclaim 2, wherein the valve body is slidable along the secondlongitudinal axis.
 4. The fluid coupling of claim 1, wherein theconnection member is slidably coupled with the housing.
 5. The fluidcoupling of claim 4, wherein the connection member is slidable betweenthe first position and the second position along a path that istransverse to the first and second longitudinal axes.
 6. The fluidcoupling of claim 1, wherein, while the connection member is in thesecond position, the connection member is coaxial with an end portdefined by the fluid coupling.
 7. The fluid coupling of claim 1, whereinthe connection member is threaded to releasably couple with the matingcoupling.
 8. The fluid coupling of claim 1, wherein the connectionmember is prevented from moving away from the first position while thefluid coupling and the mating coupling are disconnected from each other.9. The fluid coupling of claim 1, wherein the valve body is slidablycoupled with the housing and prevented from sliding unless theconnection member is in the second position.
 10. A fluid couplingcomprising: a housing defining: (i) a first longitudinal axis and (ii) asecond longitudinal axis that is parallel to the first longitudinalaxis; a connection member configured to releasably couple a matingcoupling to the fluid coupling, the connection member movably coupled tothe housing; a valve body coupled with an end portion that defines anend port of the fluid coupling, the valve body including a spring-loadedvalve sleeve that is movable along the second longitudinal axis to openand close a fluid flow path through the fluid coupling, the valve bodycoaxial with the second longitudinal axis and slidably coupled with thehousing such that the valve body and the end portion that defines theend port are movable along the second longitudinal axis; and a flexiblemember coupled to the housing and to a perimeter of the connectionmember, wherein the flexible member reconfigures while the connectionmember is moved between the first position and the second position. 11.The fluid coupling of claim 10, with the connection member is movablebetween a first position in which the connection member is coaxial withthe first longitudinal axis and a second position in which theconnection member is coaxial with the second longitudinal axis.
 12. Thefluid coupling of claim 11, wherein the connection member is slidablebetween the first position and the second position along a path that istransverse to the second longitudinal axis.
 13. The fluid coupling ofclaim 10, wherein the flexible member seals a space adjacent to thevalve sleeve so as to maintain sterility barrier between the fluid flowpath and ambient.
 14. The fluid coupling of claim 10, wherein the valvebody is prevented from sliding relative to the housing unless theconnection member is in the second position.
 15. The fluid coupling ofclaim 10, wherein the connection member is threaded to releasably couplewith the mating coupling.
 16. The fluid coupling of claim 10, whereinthe connection member is prevented from moving away from the firstposition while the fluid coupling and the mating coupling aredisconnected from each other.
 17. The fluid coupling of claim 10,further comprising a counter mechanism coupled to the housing andconfigured for tracking a number of times the fluid coupling has beenused.
 18. The fluid coupling of claim 10, further comprising anunlatching mechanism movably coupled to the housing and configured to,upon actuation, release the valve body from being latched in anoperative position relative to the housing.